145-815: Perrigo Company plc ( Hebrew : פריגו ) is an American Irish -registered manufacturer of private label over-the-counter pharmaceuticals , and while 70% of Perrigo's net sales are from the U.S. healthcare system, Perrigo is legally headquartered in Ireland for tax purposes, which accounts for 0.60% of net sales. In 2013, Perrigo completed the sixth-largest US corporate tax inversion in history when it reregistered its tax status to Ireland to avoid U.S. corporate taxes. Perrigo maintains its corporate headquarters in Grand Rapids, Michigan , within Michigan State University 's Grand Rapids Innovation Park. Perrigo engages in
290-720: A medical practitioner 's supervision like ibuprofen . In 2014, the FDA added an Ebola treatment being developed by Canadian pharmaceutical company Tekmira to the Fast Track program , but halted the phase 1 trials in July pending the receipt of more information about how the drug works. This was widely viewed as increasingly important in the face of a major outbreak of the disease in West Africa that began in late March 2014 and ended in June 2016. During
435-460: A "FDA Compliant" or "FDA Acceptable". Medical countermeasures (MCMs) are products such as biologics and pharmaceutical drugs that can protect from or treat the health effects of a chemical, biological, radiological, or nuclear (CBRN) attack. MCMs can also be used for prevention and diagnosis of symptoms associated with CBRN attacks or threats. The FDA runs a program called the "FDA Medical Countermeasures Initiative" (MCMi), with programs funded by
580-674: A Hebrew form. Medieval Hebrew added 6421 words to (Modern) Hebrew. The approximate number of new lexical items in Israeli is 17,000 (cf. 14,762 in Even-Shoshan 1970 [...]). With the inclusion of foreign and technical terms [...], the total number of Israeli words, including words of biblical, rabbinic and medieval descent, is more than 60,000. In Israel, Modern Hebrew is currently taught in institutions called Ulpanim (singular: Ulpan). There are government-owned, as well as private, Ulpanim offering online courses and face-to-face programs. Modern Hebrew
725-425: A REMS program called iPLEDGE . Generic drugs are chemical and therapeutic equivalents of name-brand drugs, normally whose patents have expired. Approved generic drugs should have the same dosage, safety, effectiveness, strength, stability, and quality, as well as route of administration. In general, they are less expensive than their name brand counterparts, are manufactured and marketed by rival companies and, in
870-745: A case. The FDA has a number of field offices across the United States, in addition to international locations in China, India, Europe, the Middle East, and Latin America. As of 2021, the FDA had responsibility for overseeing $ 2.7 trillion in food, medical, and tobacco products. Some 54% of its budget derives from the federal government, and 46% is covered by industry user fees for FDA services. For example, pharmaceutical firms pay fees to expedite drug reviews. According to Forbes, pharmaceutical firms provide 75% of
1015-583: A century ago, was fluent enough in this idiom to be able to follow the Mishna Berurah without any trouble." Hebrew has been revived several times as a literary language, most significantly by the Haskalah (Enlightenment) movement of early and mid-19th-century Germany. In the early 19th century, a form of spoken Hebrew had emerged in the markets of Jerusalem between Jews of different linguistic backgrounds to communicate for commercial purposes. This Hebrew dialect
1160-513: A company may advertise or promote a drug only for the specific indication or medical use for which it was approved by FDA. Also, an advertisement must contain a "fair balance" between the benefits and the risks (side effects) of a drug. The regulation of drug advertising in the U.S. is divided between the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC), based on whether
1305-426: A complaint brought against the FDA by Mylan Laboratories Inc. of Pittsburgh . When its application to manufacture generics were subjected to repeated delays by the FDA, Mylan, convinced that it was being discriminated against, soon began its own private investigation of the agency in 1987. Mylan eventually filed suit against two former FDA employees and four drug-manufacturing companies, charging that corruption within
1450-649: A corollary Hebrew ceased to function as a spoken language around the same time. Moshe Zvi Segal , Joseph Klausner and Ben Yehuda are notable exceptions to this view. During the latter half of the 20th century, accumulating archaeological evidence and especially linguistic analysis of the Dead Sea Scrolls has disproven that view. The Dead Sea Scrolls, uncovered in 1946–1948 near Qumran revealed ancient Jewish texts overwhelmingly in Hebrew, not Aramaic. The Qumran scrolls indicate that Hebrew texts were readily understandable to
1595-562: A distinct style of philosophical Hebrew. This is used in the translations made by the Ibn Tibbon family. (Original Jewish philosophical works were usually written in Arabic. ) Another important influence was Maimonides , who developed a simple style based on Mishnaic Hebrew for use in his law code, the Mishneh Torah . Subsequent rabbinic literature is written in a blend between this style and
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#17328584968131740-579: A gradually accepted movement. It was not, however, until the 1904–1914 Second Aliyah that Hebrew had caught real momentum in Ottoman Palestine with the more highly organized enterprises set forth by the new group of immigrants. When the British Mandate of Palestine recognized Hebrew as one of the country's three official languages (English, Arabic, and Hebrew, in 1922), its new formal status contributed to its diffusion. A constructed modern language with
1885-463: A literary language down through the Byzantine period from the 4th century CE. The exact roles of Aramaic and Hebrew remain hotly debated. A trilingual scenario has been proposed for the land of Israel. Hebrew functioned as the local mother tongue with powerful ties to Israel's history, origins and golden age and as the language of Israel's religion; Aramaic functioned as the international language with
2030-532: A literary language, especially in Spain, as the language of commerce between Jews of different native languages, and as the liturgical language of Judaism, evolving various dialects of literary Medieval Hebrew , until its revival as a spoken language in the late 19th century. In May 2023, Scott Stripling published the finding of what he claims to be the oldest known Hebrew inscription, a curse tablet found at Mount Ebal , dated from around 3200 years ago. The presence of
2175-432: A long period of time. The studies are progressively longer, gradually adding more individuals as they progress from stage I to stage III, normally over a period of years, and normally involve drug companies, the government and its laboratories, and often medical schools and hospitals and clinics. However, any exceptions to the aforementioned process are subject to strict review and scrutiny and conditions, and are only given if
2320-529: A multinational generic pharmaceutical company. As a result of the acquisition, Arkin owned 9% of Perrigo, and was appointed as Vice Chairman of the company. In July 2013, Perrigo announced that it would execute a corporate tax inversion to Ireland in order to avoid U.S. corporate taxes, via an $ 8.6 billion acquisition of Irish-based Elan Corporation . As of November 2018, Perrigo is the sixth-largest U.S. tax inversion in history. Over 70% of Perrigo's sales, and an even greater percentage of Perrigo profits, are from
2465-555: A new master plan for this expansion in December 2018, and construction is expected to be completed by 2035, dependent on GSA appropriations. The Office of Regulatory Affairs is considered the agency's "eyes and ears", conducting the vast majority of the FDA's work in the field. Its employees, known as Consumer Safety Officers, or more commonly known simply as investigators, inspect production, warehousing facilities, investigate complaints, illnesses, or outbreaks, and review documentation in
2610-647: A number of Resident Posts, which are FDA remote offices that serve a particular geographic area. ORA also includes the Agency's network of regulatory laboratories, which analyze any physical samples taken. Though samples are usually food-related, some laboratories are equipped to analyze drugs, cosmetics, and radiation-emitting devices. The Office of Criminal Investigations was established in 1991 to investigate criminal cases. To do so, OCI employs approximately 200 Special Agents nationwide who, unlike ORA Investigators, are armed, have badges, and do not focus on technical aspects of
2755-594: A privately held manufacturer of over-the-counter companion animal healthcare products. On 11 February 2013, Perrigo announced the completion of the acquisition of Rosemont Pharmaceuticals Ltd., a specialty and generic prescription pharmaceutical company focused on the manufacturing and marketing of oral liquid formulations. On 29 July 2013, the firm announced that it would acquire Élan , a pharmaceutical firm based in Dublin. The Élan acquisition enabled Perrigo to reincorporate as an Irish company using Élan's headquarters (although
2900-414: A producer of over-the-counter store brand infant formula and baby foods in the United States, Canada, Mexico and China. On 20 January 2011, the firm announced that it would acquire Paddock Laboratories Inc., with the deal expected to close in fiscal 2012. In September 2012, Perrigo announced its intention to enter the animal wellness category by acquiring the assets of Sergeant's Pet Care Products, Inc.,
3045-494: A role in monitoring safety through influence on ingredients, but they lack legal authority. According to the ACSH, it has reviewed about 1,200 ingredients and has suggested that several hundred be restricted—but there is no standard or systemic method for reviewing chemicals for safety, or a clear definition of what 'safety' even means so that all chemicals get tested on the same basis. However, on December 29, 2022, President Biden signed
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#17328584968133190-523: A satisfied requirement. The FDA does not approve applied coatings used in the food processing industry . There is no review process to approve the composition of nonstick coatings; nor does the FDA inspect or test these materials. Through their governing of processes, however, the FDA does have a set of regulations that cover the formulation, manufacturing, and use of nonstick coatings. Hence, materials like Polytetrafluoroethylene (Teflon) are not and cannot be considered as FDA Approved, but rather, they are
3335-535: A set of dialects evolving out of Late Biblical Hebrew and into Mishnaic Hebrew, thus including elements from both but remaining distinct from either. By the start of the Byzantine Period in the 4th century CE, Classical Hebrew ceased as a regularly spoken language, roughly a century after the publication of the Mishnah, apparently declining since the aftermath of the catastrophic Bar Kokhba revolt around 135 CE. In
3480-652: A spoken language, it continued to be used as a lingua franca among scholars and Jews traveling in foreign countries. After the 2nd century CE when the Roman Empire exiled most of the Jewish population of Jerusalem following the Bar Kokhba revolt , they adapted to the societies in which they found themselves, yet letters, contracts, commerce, science, philosophy, medicine, poetry and laws continued to be written mostly in Hebrew, which adapted by borrowing and inventing terms. After
3625-440: A substantial amount of research and at least some preliminary human testing has shown that they are believed to be somewhat safe and possibly effective. (See FDA Special Protocol Assessment about Phase III trials.) The FDA's Office of Prescription Drug Promotion (OPDP) has responsibilities that revolve around the review and regulation of prescription drug advertising and promotion. This is achieved through surveillance activities and
3770-468: A truly Semitic vocabulary and written appearance, although often European in phonology , was to take its place among the current languages of the nations. While many saw his work as fanciful or even blasphemous (because Hebrew was the holy language of the Torah and therefore some thought that it should not be used to discuss everyday matters), many soon understood the need for a common language amongst Jews of
3915-549: A vernacular in Judea until it was displaced by Aramaic, probably in the 3rd century CE. Certain Sadducee , Pharisee , Scribe , Hermit, Zealot and Priest classes maintained an insistence on Hebrew, and all Jews maintained their identity with Hebrew songs and simple quotations from Hebrew texts. While there is no doubt that at a certain point, Hebrew was displaced as the everyday spoken language of most Jews, and that its chief successor in
4060-553: A warning to that effect. According to the industry advocacy group, the American Council on Science and Health , though the cosmetic industry is primarily responsible for its own product safety, the FDA can intervene when necessary to protect the public. In general, though, cosmetics do not require pre-market approval or testing. The ACSH says that companies must place a warning note on their products if they have not been tested, and that experts in cosmetic ingredient review also play
4205-511: Is 8198, of which some 2000 are hapax legomena (the number of Biblical Hebrew roots, on which many of these words are based, is 2099). The number of attested Rabbinic Hebrew words is less than 20,000, of which (i) 7879 are Rabbinic par excellence, i.e. they did not appear in the Old Testament (the number of new Rabbinic Hebrew roots is 805); (ii) around 6000 are a subset of Biblical Hebrew; and (iii) several thousand are Aramaic words which can have
4350-620: Is a Northwest Semitic language within the Afroasiatic language family . A regional dialect of the Canaanite languages , it was natively spoken by the Israelites and remained in regular use as a first language until after 200 CE and as the liturgical language of Judaism (since the Second Temple period ) and Samaritanism . The language was revived as a spoken language in the 19th century, and
4495-401: Is a center of the FDA that regulates food additives and drugs that are given to animals. CVM regulates animal drugs, animal food including pet animal, and animal medical devices. The FDA's requirements to prevent the spread of bovine spongiform encephalopathy are also administered by CVM through inspections of feed manufacturers. CVM does not regulate vaccines for animals; these are handled by
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4640-651: Is a separate process, and the drug must be approved through an NDA first. A drug that is approved is said to be "safe and effective when used as directed". Very rare, limited exceptions to this multi-step process involving animal testing and controlled clinical trials can be granted out of compassionate use protocols. This was the case during the 2015 Ebola epidemic with the use, by prescription and authorization, of ZMapp and other experimental treatments, and for new drugs that can be used to treat debilitating and/or very rare conditions for which no existing remedies or drugs are satisfactory, or where there has not been an advance in
4785-547: Is enforcement of the Federal Food, Drug, and Cosmetic Act (FD&C). However, the agency also enforces other laws, notably Section 361 of the Public Health Service Act as well as associated regulations. Much of this regulatory-enforcement work is not directly related to food or drugs but involves other factors like regulating lasers , cellular phones , and condoms . In addition, the FDA takes control of diseases in
4930-563: Is fighting to stop businesses from using only English signs to market their services. In 2012, a Knesset bill for the preservation of the Hebrew language was proposed, which includes the stipulation that all signage in Israel must first and foremost be in Hebrew, as with all speeches by Israeli officials abroad. The bill's author, MK Akram Hasson , stated that the bill was proposed as a response to Hebrew "losing its prestige" and children incorporating more English words into their vocabulary. Hebrew
5075-713: Is located in the White Oak area of Silver Spring, Maryland . The agency has 223 field offices and 13 laboratories located across the 50 states, the United States Virgin Islands , and Puerto Rico . In 2008, the FDA began to post employees to foreign countries, including China, India, Costa Rica, Chile, Belgium, and the United Kingdom. FDA headquarters facilities are currently located in Montgomery County and Prince George's County , Maryland. Since 1990,
5220-515: Is one of several languages for which the constitution of South Africa calls to be respected in their use for religious purposes. Also, Hebrew is an official national minority language in Poland , since 6 January 2005. Hamas has made Hebrew a compulsory language taught in schools in the Gaza Strip. FDA The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of
5365-449: Is the branch of the FDA responsible for ensuring the safety and efficacy of biological therapeutic agents. These include blood and blood products, vaccines, allergenics, cell and tissue-based products, and gene therapy products. New biologics are required to go through a premarket approval process called a Biologics License Application (BLA), similar to that for drugs. The original authority for government regulation of biological products
5510-737: Is the branch of the FDA responsible for the premarket approval of all medical devices , as well as overseeing the manufacturing, performance and safety of these devices. The definition of a medical device is given in the FD&;C Act, and it includes products from the simple toothbrush to complex devices such as implantable neurostimulators . CDRH also oversees the safety performance of non-medical devices that emit certain types of electromagnetic radiation . Examples of CDRH-regulated devices include cellular phones , airport baggage screening equipment , television receivers , microwave ovens , tanning booths , and laser products . CDRH regulatory powers include
5655-560: Is the only successful large-scale example of linguistic revival . It is the only Canaanite language, as well as one of only two Northwest Semitic languages, with the other being Aramaic , still spoken today. The earliest examples of written Paleo-Hebrew date back to the 10th century BCE. Nearly all of the Hebrew Bible is written in Biblical Hebrew , with much of its present form in the dialect that scholars believe flourished around
5800-453: Is the primary official language of the State of Israel. As of 2013 , there are about 9 million Hebrew speakers worldwide, of whom 7 million speak it fluently. Currently, 90% of Israeli Jews are proficient in Hebrew, and 70% are highly proficient. Some 60% of Israeli Arabs are also proficient in Hebrew, and 30% report having a higher proficiency in Hebrew than in Arabic. In total, about 53% of
5945-696: Is used for a different purpose, or undergoes any substantial change. The most rigorous requirements apply to new molecular entities : drugs that are not based on existing medications. New drugs receive extensive scrutiny before FDA approval in a process called a new drug application (NDA). Under the Presidency of Donald Trump , the agency has worked to make the drug-approval process go faster. Critics, however, argue that FDA standards are not sufficiently rigorous to prevent unsafe or ineffective drugs from getting approval. New drugs are available only by prescription by default. A change to over-the-counter (OTC) status
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6090-536: Is used to pronounce the Hebrew Bible; however, properly it should be distinguished from the historical Biblical Hebrew of the 6th century BCE, whose original pronunciation must be reconstructed. Tiberian Hebrew incorporates the scholarship of the Masoretes (from masoret meaning "tradition"), who added vowel points and grammar points to the Hebrew letters to preserve much earlier features of Hebrew, for use in chanting
6235-451: Is voluntary. While this remains the primary tool of post-market safety surveillance , FDA requirements for post-marketing risk management are increasing. As a condition of approval, a sponsor may be required to conduct additional clinical trials , called Phase IV trials. In some cases, the FDA requires risk management plans called Risk Evaluation and Mitigation Strategies (REMS) for some drugs that require actions to be taken to ensure that
6380-630: The Chayei Adam in Hebrew, as opposed to Yiddish , as a guide to Halacha for the " average 17-year-old" (Ibid. Introduction 1). Similarly, Rabbi Yisrael Meir Kagan 's purpose in writing the Mishnah Berurah was to "produce a work that could be studied daily so that Jews might know the proper procedures to follow minute by minute". The work was nevertheless written in Talmudic Hebrew and Aramaic, since, "the ordinary Jew [of Eastern Europe] of
6525-692: The Irish Times reported that Revenue claimed Perrigo owed CGT at a rate of 33% as an "asset sale", however Perrigo claimed that the sale was part of Elan's normal "trading income", and was subject to the lower 12.5% Irish corporate tax rate, which Perrigo was able to reduce to 0% using Ireland's multinational tax BEPS tools . In June 2022, Perrigo moved its corporate headquarters from Allegan to downtown Grand Rapids, about 40 miles north, within Michigan State University's Grand Rapids Innovation Park. The company still maintains offices and production at
6670-705: The Ancient Greek Ἑβραῖος ( hebraîos ) and Aramaic 'ibrāy , all ultimately derived from Biblical Hebrew Ivri ( עברי ), one of several names for the Israelite ( Jewish and Samaritan ) people ( Hebrews ). It is traditionally understood to be an adjective based on the name of Abraham 's ancestor, Eber , mentioned in Genesis 10:21 . The name is believed to be based on the Semitic root ʕ-b-r ( ע־ב־ר ), meaning "beyond", "other side", "across"; interpretations of
6815-534: The Canaanite group of languages . Canaanite languages are a branch of the Northwest Semitic family of languages. Hebrew was the spoken language in the Iron Age kingdoms of Israel and Judah during the period from about 1200 to 586 BCE. Epigraphic evidence from this period confirms the widely accepted view that the earlier layers of biblical literature reflect the language used in these kingdoms. Furthermore,
6960-671: The Center for Drug Evaluation and Research (CDER), the Center for Devices and Radiological Health (CDRH), the Center for Biologics Evaluation and Research (CBER) and offices for the Center for Veterinary Medicine (CVM). With the passing of the FDA Reauthorization Act of 2017, the FDA projects a 64% increase in employees to 18,000 over the next 15 years and wants to add approximately 1,600,000 square feet (150,000 square metres) of office and special use space to their existing facilities. The National Capital Planning Commission approved
7105-579: The Department of Health and Human Services . The FDA is responsible for protecting and promoting public health through the control and supervision of food safety , tobacco products, caffeine products, dietary supplements , prescription and over-the-counter pharmaceutical drugs (medications), vaccines , biopharmaceuticals , blood transfusions , medical devices , electromagnetic radiation emitting devices (ERED), cosmetics, animal foods & feed and veterinary products . The FDA's primary focus
7250-557: The Gospel of Matthew . (See the Hebrew Gospel hypothesis or Language of Jesus for more details on Hebrew and Aramaic in the gospels.) The term "Mishnaic Hebrew" generally refers to the Hebrew dialects found in the Talmud , excepting quotations from the Hebrew Bible. The dialects organize into Mishnaic Hebrew (also called Tannaitic Hebrew, Early Rabbinic Hebrew, or Mishnaic Hebrew I), which
7395-491: The Latin alphabet of ancient Rome . The Gezer calendar is written without any vowels , and it does not use consonants to imply vowels even in the places in which later Hebrew spelling requires them. Numerous older tablets have been found in the region with similar scripts written in other Semitic languages, for example, Proto-Sinaitic . It is believed that the original shapes of the script go back to Egyptian hieroglyphs , though
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#17328584968137540-655: The Maccabean Revolt (167–160 BCE) and the emergence of the Hasmonean kingdom , the Great Jewish Revolt (66–73 CE), and the Bar Kokhba revolt (132–135 CE). The nationalist significance of Hebrew manifested in various ways throughout this period. Michael Owen Wise notes that "Beginning with the time of the Hasmonean revolt [...] Hebrew came to the fore in an expression akin to modern nationalism. A form of classical Hebrew
7685-525: The Second Aliyah , it replaced a score of languages spoken by Jews at that time. Those languages were Jewish dialects of local languages, including Judaeo-Spanish (also called "Judezmo" and "Ladino"), Yiddish , Judeo-Arabic and Bukhori (Tajiki), or local languages spoken in the Jewish diaspora such as Russian , Persian and Arabic . The major result of the literary work of the Hebrew intellectuals along
7830-639: The coronavirus pandemic , FDA granted emergency use authorization for personal protective equipment (PPE), in vitro diagnostic equipment, ventilators and other medical devices. On March 18, 2020, FDA inspectors postponed most foreign facility inspections and all domestic routine surveillance facility inspections. In contrast, the USDA's Food Safety and Inspection Service (FSIS) continued inspections of meatpacking plants, which resulted in 145 FSIS field employees who tested positive for COVID-19, and three who died. The Center for Biologics Evaluation and Research
7975-455: The literary and liturgical language into everyday spoken language . However, his brand of Hebrew followed norms that had been replaced in Eastern Europe by different grammar and style, in the writings of people like Ahad Ha'am and others. His organizational efforts and involvement with the establishment of schools and the writing of textbooks pushed the vernacularization activity into
8120-609: The official language of the State of Israel . Estimates of worldwide usage include five million speakers in 1998, and over nine million people in 2013. After Israel, the United States has the largest Hebrew-speaking population, with approximately 220,000 fluent speakers (see Israeli Americans and Jewish Americans ). Modern Hebrew is the official language of the State of Israel, while pre-revival forms of Hebrew are used for prayer or study in Jewish and Samaritan communities around
8265-537: The ostraca found near Lachish , which describe events preceding the final capture of Jerusalem by Nebuchadnezzar and the Babylonian captivity of 586 BCE. In its widest sense, Biblical Hebrew refers to the spoken language of ancient Israel flourishing between c. 1000 BCE and c. 400 CE . It comprises several evolving and overlapping dialects. The phases of Classical Hebrew are often named after important literary works associated with them. Sometimes
8410-606: The '2023 Consolidated Budget Act', which includes the 'Cosmetics Regulatory Modernization Act of 2022 (MoCRA)', which is a stricter regulation that is different from the previous regulations. MoCRA requires compliance with matters such as serious adverse event reporting, safety substantiation, additional labeling, record keeping, and Good Manufacturing Practices (GMP). MoCRA also calls on the FDA to grant Mandatory Recall Authority and establish regulations for GMP rules, flavor allergen labeling rules, and testing methods for cosmetics containing talc. The Center for Veterinary Medicine (CVM)
8555-592: The 10th century BCE at the beginning of the Monarchic period , the traditional time of the reign of David and Solomon . Classified as Archaic Biblical Hebrew , the calendar presents a list of seasons and related agricultural activities. The Gezer calendar (named after the city in whose proximity it was found) is written in an old Semitic script, akin to the Phoenician one that, through the Greeks and Etruscans , later became
8700-547: The 1980s in the USSR , Hebrew studies reappeared due to people struggling for permission to go to Israel ( refuseniks ). Several of the teachers were imprisoned, e.g. Yosef Begun , Ephraim Kholmyansky , Yevgeny Korostyshevsky and others responsible for a Hebrew learning network connecting many cities of the USSR. Standard Hebrew, as developed by Eliezer Ben-Yehuda, was based on Mishnaic spelling and Sephardi Hebrew pronunciation. However,
8845-406: The 1990s, accounted for about a third of all prescriptions written in the United States. For a pharmaceutical company to gain approval to produce a generic drug, the FDA requires scientific evidence that the generic drug is interchangeable with or therapeutically equivalent to the originally approved drug. This is called an Abbreviated New Drug Application (ANDA). 80% of prescription drugs sold in
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#17328584968138990-601: The 19th century was a lexical modernization of Hebrew. New words and expressions were adapted as neologisms from the large corpus of Hebrew writings since the Hebrew Bible, or borrowed from Arabic (mainly by Ben-Yehuda) and older Aramaic and Latin. Many new words were either borrowed from or coined after European languages, especially English, Russian, German, and French. Modern Hebrew became an official language in British-ruled Palestine in 1921 (along with English and Arabic), and then in 1948 became an official language of
9135-594: The 6th century BCE, during the time of the Babylonian captivity . For this reason, Hebrew has been referred to by Jews as Lashon Hakodesh ( לְשׁוֹן הַקֹּדֶש , lit. ' the holy tongue ' or ' the tongue [of] holiness ' ) since ancient times. The language was not referred to by the name Hebrew in the Bible , but as Yehudit ( transl. ' Judean ' ) or Səpaṯ Kəna'an ( transl. "the language of Canaan " ). Mishnah Gittin 9:8 refers to
9280-532: The Allegan campus. In 2023, its subsidiary, HRA Pharma, received approval from the FDA to sell an over the counter women’s contraception drug called Opill. On 9 January 2008, the firm acquired Galpharm Healthcare, Ltd. , a supplier of over-the-counter store brand pharmaceuticals in the United Kingdom. On 16 September 2008, the firm acquired J.B. Laboratories. On 6 October 2008, it acquired Laboratorios Diba S.A., enabling
9425-579: The Aramaized Rabbinic Hebrew of the Talmud. Hebrew persevered through the ages as the main language for written purposes by all Jewish communities around the world for a large range of uses—not only liturgy, but also poetry, philosophy, science and medicine, commerce, daily correspondence and contracts. There have been many deviations from this generalization such as Bar Kokhba 's letters to his lieutenants, which were mostly in Aramaic, and Maimonides' writings, which were mostly in Arabic; but overall, Hebrew did not cease to be used for such purposes. For example,
9570-503: The British Mandate who at the turn of the 20th century were arriving in large numbers from diverse countries and speaking different languages. A Committee of the Hebrew Language was established. After the establishment of Israel, it became the Academy of the Hebrew Language . The results of Ben-Yehuda's lexicographical work were published in a dictionary ( The Complete Dictionary of Ancient and Modern Hebrew , Ben-Yehuda Dictionary ). The seeds of Ben-Yehuda's work fell on fertile ground, and by
9715-434: The CEO role at Valeant. Upon Papa's departure, John Hendrickson , who was at the time the company's president, took on the additional roles of chairman and CEO. Hendrickson was succeeded by Uwe Roehrhoff in January, 2018. Murray S. Kessler succeeded Roehroff already in October of that same year. As of July 2023, Patrick Lockwood-Taylor is the current President and CEO. On 20 December 2018, the Financial Times reported that
9860-399: The FD&C Act. OCI Special Agents often come from other criminal investigations backgrounds, and frequently work closely with the Federal Bureau of Investigation , Assistant Attorney General , and even Interpol . OCI receives cases from a variety of sources—including ORA, local agencies, and the FBI, and works with ORA Investigators to help develop the technical and science-based aspects of
10005-555: The FDA exercises differ from one category to the next. Furthermore, legislation had granted the FDA a variety of means to address violations of standards for a given substance category. Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA is responsible for ensuring that manufacturers and distributors of dietary supplements and dietary ingredients meet the current requirements. These manufacturers and distributors are not allowed to advertise their products in an adulterated way, and they are responsible for evaluating
10150-435: The FDA has had employees and facilities on 130 acres (53 hectares) of the White Oak Federal Research Center in the White Oak area of Silver Spring, Maryland . In 2001, the General Services Administration (GSA) began new construction on the campus to consolidate the FDA's 25 existing operations in the Washington metropolitan area , its headquarters in Rockville , and several fragmented office buildings. The first building,
10295-636: The FDA released a statement regarding new guidelines to help food and drug manufacturers "implement protections against potential attacks on the U.S. food supply". One of the guidelines includes the Intentional Adulteration (IA) rule, which requires strategies and procedures by the food industry to reduce the risk of compromise in facilities and processes that are significantly vulnerable. The FDA also uses tactics of regulatory shaming, mainly through online publication of non-compliance, warning letters, and "shaming lists." Regulation by shaming harnesses firms' sensitivity to reputational damage. For example, in 2018,
10440-581: The FDA's drug review budget Emergency Use Authorization (EUA) is a mechanism that was created to facilitate the availability and use of medical countermeasures, including vaccines and personal protective equipment, during public health emergencies such as the Zika virus epidemic, the Ebola virus epidemic and the COVID-19 pandemic. The programs for safety regulation vary widely by the type of product, its potential risks, and
10585-871: The Food and Drug Administration is governed by various statutes enacted by the United States Congress and interpreted by the FDA. Pursuant to the Federal Food, Drug, and Cosmetic Act and accompanying legislation, the FDA has authority to oversee the quality of substances sold as food in the United States, and to monitor claims made in the labeling of both the composition and the health benefits of foods. The FDA subdivides substances that it regulates as food into various categories—including foods, food additives , added substances (human-made substances that are not intentionally introduced into food, but nevertheless end up in it), and dietary supplements . Dietary supplements or dietary ingredients include vitamins, minerals, herbs, amino acids , and enzymes . Specific standards
10730-516: The Great conquered Babylon, he allowed the Jewish people to return from captivity. In time, a local version of Aramaic came to be spoken in Israel alongside Hebrew. By the beginning of the Common Era , Aramaic was the primary colloquial language of Samarian , Babylonian and Galileean Jews, and western and intellectual Jews spoke Greek , but a form of so-called Rabbinic Hebrew continued to be used as
10875-432: The Hebrew name of god , Yahweh, as three letters, Yod-Heh-Vav (YHV), according to the author and his team meant that the tablet is Hebrew and not Canaanite. However, practically all professional archeologists and epigraphers apart from Stripling's team claim that there is no text on this object. In July 2008, Israeli archaeologist Yossi Garfinkel discovered a ceramic shard at Khirbet Qeiyafa that he claimed may be
11020-588: The Hebrew Bible. The Masoretes inherited a biblical text whose letters were considered too sacred to be altered, so their markings were in the form of pointing in and around the letters. The Syriac alphabet , precursor to the Arabic alphabet , also developed vowel pointing systems around this time. The Aleppo Codex , a Hebrew Bible with the Masoretic pointing, was written in the 10th century, likely in Tiberias, and survives into
11165-608: The Irish Revenue Commissioners levied a €1.64 billion (not including penalties and interest) Irish tax claim on Perrigo for unpaid capital gains tax (CGT) from the 2013 sale of Tysabri to Biogen by Elan, which happened months before Perrigo's acquisition of Elan. The claim is the second largest ever issued by the Revenue Commissioners in Irish history, after Apple's €13 billion Irish tax fine . On 21 December 2018,
11310-454: The Israeli population speaks Hebrew as a native language, while most of the rest speak it fluently. In 2013 Hebrew was the native language of 49% of Israelis over the age of 20, with Russian , Arabic , French , English , Yiddish and Ladino being the native tongues of most of the rest. Some 26% of immigrants from the former Soviet Union and 12% of Arabs reported speaking Hebrew poorly or not at all. Steps have been taken to keep Hebrew
11455-623: The Life Sciences Laboratory, was dedicated and opened with 104 employees in December 2003. As of December 2018, the FDA campus has a population of 10,987 employees housed in approximately 3,800,000 square feet (350,000 square metres) of space, divided into ten offices and four laboratory buildings. The campus houses the Office of the Commissioner (OC), the Office of Regulatory Affairs (ORA),
11600-417: The Middle East was the closely related Aramaic language, then Greek , scholarly opinions on the exact dating of that shift have changed very much. In the first half of the 20th century, most scholars followed Abraham Geiger and Gustaf Dalman in thinking that Aramaic became a spoken language in the land of Israel as early as the beginning of Israel's Hellenistic period in the 4th century BCE, and that as
11745-654: The Talmud, the Gemara , generally comments on the Mishnah and Baraitot in two forms of Aramaic. Nevertheless, Hebrew survived as a liturgical and literary language in the form of later Amoraic Hebrew, which occasionally appears in the text of the Gemara, particularly in the Jerusalem Talmud and the classical aggadah midrashes . Hebrew was always regarded as the language of Israel's religion, history and national pride, and after it faded as
11890-455: The Talmud, various regional literary dialects of Medieval Hebrew evolved. The most important is Tiberian Hebrew or Masoretic Hebrew, a local dialect of Tiberias in Galilee that became the standard for vocalizing the Hebrew Bible and thus still influences all other regional dialects of Hebrew. This Tiberian Hebrew from the 7th to 10th century CE is sometimes called "Biblical Hebrew" because it
12035-541: The U.S. healthcare system. In April 2015, Perrigo received an unsolicited buy-out offer from Mylan of $ 29 billion, which was ultimately rejected by management and shareholders. In May 2016, Perrigo investors sued the company over statements made during the Mylan bid, which were said to have persuaded shareholders to vote against the deal. In the months prior to this suit, the company's chairman and CEO, Joseph Papa , who has been credited with "fending off" Mylan's bid, left to take
12180-477: The United States are generic brands. In 1989, a major scandal erupted involving the procedures used by the FDA to approve generic drugs for sale to the public. Charges of corruption in generic drug approval first emerged in 1988 during the course of an extensive congressional investigation into the FDA. The oversight subcommittee of the United States House Energy and Commerce Committee resulted from
12325-560: The United States, the United Kingdom, and Mexico. This segment offers analgesic , cough/cold/allergy/sinus, gastrointestinal, smoking cessation , first aid , antacids, hemorrhoidal remedies, motion sickness, sleep aid products, feminine hygiene products, vitamin, and nutritional supplement products. The Rx Pharmaceuticals segment produces generic prescription drugs in the United States. This segment provides creams, ointments, lotions, gels, and solutions, as well as nasal sprays, foams, and transdermal devices. Believing that Rx business has
12470-480: The ability to speak the language and attempted to promote its use. According to the Jerusalem Talmud , Megillah 1:9: "Rebbi Jonathan from Bet Guvrrin said, four languages are appropriate that the world should use them, and they are these: The Foreign Language (Greek) for song, Latin for war, Syriac for elegies, Hebrew for speech. Some are saying, also Assyrian (Hebrew script) for writing." The later section of
12615-470: The above phases of spoken Classical Hebrew are simplified into "Biblical Hebrew" (including several dialects from the 10th century BCE to 2nd century BCE and extant in certain Dead Sea Scrolls) and "Mishnaic Hebrew" (including several dialects from the 3rd century BCE to the 3rd century CE and extant in certain other Dead Sea Scrolls). However, today most Hebrew linguists classify Dead Sea Scroll Hebrew as
12760-450: The acquisition (for repricing), manufacture, and sale of consumer healthcare products, generic prescription drugs, and active pharmaceutical ingredients (APIs), primarily in the United States, from its base in Ireland. On 21 December 2018, Perrigo suffered its biggest one-day share price fall in its history after the Irish Revenue Commissioners issued a tax claim against Perrigo that equated to half of its market value. L. Perrigo Company
12905-463: The acquisition in April 2022. The following is an illustration of the company's major mergers and acquisitions and historical predecessors (this is not a comprehensive list): The company operates in three segments; Consumer Self-care Americas, Rx Pharmaceuticals, and Consumer Self-Care International. The Consumer Self-care Americas segment produces over-the-counter pharmaceutical and nutritional products in
13050-757: The agency published an online "black list", in which it named dozens of branded drug companies that are supposedly using unlawful or unethical means to attempt to impede competition from generic drug companies. The FDA frequently works with other federal agencies, including the Department of Agriculture , the Drug Enforcement Administration , Customs and Border Protection , and the Consumer Product Safety Commission . They also often work with local and state government agencies in performing regulatory inspections and enforcement actions. The regulation of food and dietary supplements by
13195-468: The authority to require certain technical reports from the manufacturers or importers of regulated products, to require that radiation-emitting products meet mandatory safety performance standards, to declare regulated products defective, and to order the recall of defective or noncompliant products. CDRH also conducts limited amounts of direct product testing. Clearance requests are required for medical devices that prove they are "substantially equivalent" to
13340-552: The average Jew, and that the language had evolved since Biblical times as spoken languages do. Recent scholarship recognizes that reports of Jews speaking in Aramaic indicate a multilingual society, not necessarily the primary language spoken. Alongside Aramaic, Hebrew co-existed within Israel as a spoken language. Most scholars now date the demise of Hebrew as a spoken language to the end of the Roman period , or about 200 CE. It continued on as
13485-535: The beginning of the 20th century, Hebrew was well on its way to becoming the main language of the Jewish population of both Ottoman and British Palestine. At the time, members of the Old Yishuv and a very few Hasidic sects, most notably those under the auspices of Satmar , refused to speak Hebrew and spoke only Yiddish. In the Soviet Union, the use of Hebrew, along with other Jewish cultural and religious activities,
13630-473: The case of medical devices, drugs, biological products, and other items where it may be difficult to conduct a physical examination or take a physical sample of the product. The Office of Regulatory Affairs is divided into five regions, which are further divided into 20 districts. The districts are based roughly on the geographic divisions of the Federal court system . Each district comprises a main district office and
13775-544: The company to market its products in Mexico. On 13 November 2008, it acquired Unico Holdings, a manufacturer of store brand pediatric electrolytes, enemas and feminine hygiene products for retail consumers in the U.S. On 1 March 2010, the firm acquired Orion Laboratories Pty, Ltd., a supplier of over-the-counter (OTC) store brand pharmaceutical products in Australia and New Zealand . On 23 March 2010, it acquired PBM Holdings, Inc.,
13920-596: The composition of 1 Maccabees in archaizing Hebrew, Hasmonean coinage under John Hyrcanus (134-104 BCE), and coins from both the Great Revolt and Bar Kokhba Revolt featuring exclusively Hebrew and Palaeo-Hebrew script inscriptions. This deliberate use of Hebrew and Paleo-Hebrew script in official contexts, despite limited literacy, served as a symbol of Jewish nationalism and political independence. The Christian New Testament contains some Semitic place names and quotes. The language of such Semitic glosses (and in general
14065-410: The content of Hebrew inscriptions suggests that the written texts closely mirror the spoken language of that time. Scholars debate the degree to which Hebrew was a spoken vernacular in ancient times following the Babylonian exile when the predominant international language in the region was Old Aramaic . Hebrew was extinct as a colloquial language by late antiquity , but it continued to be used as
14210-502: The contexts varying from household pets to human sperm donated for use in assisted reproduction . The FDA is led by the commissioner of Food and Drugs , appointed by the President with the advice and consent of the Senate . The commissioner reports to the secretary of health and human services . Robert Califf is the current commissioner as of February 17, 2022. The FDA's headquarters
14355-563: The dialects of Classical Hebrew that functioned as a living language in the land of Israel. A transitional form of the language occurs in the other works of Tannaitic literature dating from the century beginning with the completion of the Mishnah. These include the halachic Midrashim ( Sifra , Sifre , Mekhilta etc.) and the expanded collection of Mishnah-related material known as the Tosefta . The Talmud contains excerpts from these works, as well as further Tannaitic material not attested elsewhere;
14500-466: The drug in question is a prescription drug or an over-the-counter (OTC) drug. The FDA oversees the advertising of prescription drugs, while the FTC regulates the advertising of OTC drugs. The term off-label refers to the practice of prescribing a drug for a different purpose than what the FDA approved. Due to this approval requirement, manufacturers were prohibited from advertising COVID-19 vaccines during
14645-416: The drug is used safely. For example, thalidomide can cause birth defects, but has uses that outweigh the risks if men and women taking the drugs do not conceive a child; a REMS program for thalidomide mandates an auditable process to ensure that people taking the drug take action to avoid pregnancy; many opioid drugs have REMS programs to avoid addiction and diversion of drugs. The drug isotretinoin has
14790-423: The earliest Hebrew writing yet discovered, dating from around 3,000 years ago. Hebrew University archaeologist Amihai Mazar said that the inscription was "proto-Canaanite" but cautioned that "[t]he differentiation between the scripts, and between the languages themselves in that period, remains unclear", and suggested that calling the text Hebrew might be going too far. The Gezer calendar also dates back to
14935-513: The earliest speakers of Modern Hebrew had Yiddish as their native language and often introduced calques from Yiddish and phono-semantic matchings of international words. Despite using Sephardic Hebrew pronunciation as its primary basis, modern Israeli Hebrew has adapted to Ashkenazi Hebrew phonology in some respects, mainly the following: The vocabulary of Israeli Hebrew is much larger than that of earlier periods. According to Ghil'ad Zuckermann : The number of attested Biblical Hebrew words
15080-678: The early 1990s, the U.S. Securities and Exchange Commission filed securities fraud charges against the Bolar Pharmaceutical Company, a major generic manufacturer based in Long Island, New York. Over-the-counter (OTC) are drugs like aspirin that do not require a doctor's prescription. The FDA has a list of approximately 800 such approved ingredients that are combined in various ways to create more than 100,000 OTC drug products. Many OTC drug ingredients had been previously approved prescription drugs now deemed safe enough for use without
15225-518: The early 6th century BCE, the Neo-Babylonian Empire conquered the ancient Kingdom of Judah , destroying much of Jerusalem and exiling its population far to the east in Babylon . During the Babylonian captivity , many Israelites learned Aramaic, the closely related Semitic language of their captors. Thus, for a significant period, the Jewish elite became influenced by Aramaic. After Cyrus
15370-654: The executive offices remained in Allegan), lowering its effective tax rate (called a tax inversion ). In November 2014, Perrigo announced it had agreed to buy Belgian health-products provider Omega Pharma approximately $ 4.5 billion (€3.6 billion). The transaction was completed in March 2015. In August 2016, the company announced it would acquire US national distributor of over-the-counter medicines, Geiss, Destin & Dunn. In May 2019, Perrigo announced it would acquire Ranir Global Holdings LLC, boosting its oral self-care offering, with
15515-648: The federal agency resulted in racketeering and in violations of antitrust law . "The order in which new generic drugs were approved was set by the FDA employees even before drug manufacturers submitted applications" and, according to Mylan, this illegal procedure was followed to give preferential treatment to certain companies. During the summer of 1989, three FDA officials (Charles Y. Chang, David J. Brancato, Walter Kletch) pleaded guilty to criminal charges of accepting bribes from generic drugs makers, and two companies ( Par Pharmaceutical and its subsidiary Quad Pharmaceuticals) pleaded guilty to giving bribes. Furthermore, it
15660-436: The federal government. It helps support "partner" agencies and organisations prepare for public health emergencies that could require MCMs. The Center for Drug Evaluation and Research uses different requirements for the three main drug product types: new drugs, generic drugs, and over-the-counter drugs. A drug is considered "new" if it is made by a different manufacturer, uses different excipients or inactive ingredients,
15805-703: The first Middle East printing press, in Safed (modern Israel), produced a small number of books in Hebrew in 1577, which were then sold to the nearby Jewish world. This meant not only that well-educated Jews in all parts of the world could correspond in a mutually intelligible language, and that books and legal documents published or written in any part of the world could be read by Jews in all other parts, but that an educated Jew could travel and converse with Jews in distant places, just as priests and other educated Christians could converse in Latin. For example, Rabbi Avraham Danzig wrote
15950-406: The generic term for these passages is Baraitot . The dialect of all these works is very similar to Mishnaic Hebrew. About a century after the publication of the Mishnah, Mishnaic Hebrew fell into disuse as a spoken language. By the third century CE, sages could no longer identify the Hebrew names of many plants mentioned in the Mishnah. Only a few sages, primarily in the southern regions, retained
16095-545: The issuance of enforcement letters to pharmaceutical manufacturers. Advertising and promotion for over-the-counter drugs is regulated by the Federal Trade Commission . The FDA also implements regulatory oversight through engagement with third-party enforcer-firms. It expects pharmaceutical companies to ensure that third-party suppliers and labs comply with the agency's health and safety guidelines . The drug advertising regulation contains two broad requirements: (1)
16240-456: The language as Ivrit , meaning Hebrew; however, Mishnah Megillah refers to the language as Ashurit , meaning Assyrian , which is derived from the name of the alphabet used , in contrast to Ivrit , meaning the Paleo-Hebrew alphabet . Hebrew ceased to be a regular spoken language sometime between 200 and 400 CE, as it declined in the aftermath of the unsuccessful Bar Kokhba revolt , which
16385-458: The language spoken by Jews in scenes from the New Testament) is often referred to as "Hebrew" in the text, although this term is often re-interpreted as referring to Aramaic instead and is rendered accordingly in recent translations. Nonetheless, these glosses can be interpreted as Hebrew as well. It has been argued that Hebrew, rather than Aramaic or Koine Greek, lay behind the composition of
16530-464: The language. The revival of the Hebrew language as a mother tongue was initiated in the late 19th century by the efforts of Ben-Yehuda. He joined the Jewish national movement and in 1881 immigrated to Palestine , then a part of the Ottoman Empire . Motivated by the surrounding ideals of renovation and rejection of the diaspora " shtetl " lifestyle, Ben-Yehuda set out to develop tools for making
16675-720: The newly declared State of Israel . Hebrew is the most widely spoken language in Israel today. In the Modern Period, from the 19th century onward, the literary Hebrew tradition revived as the spoken language of modern Israel, called variously Israeli Hebrew , Modern Israeli Hebrew , Modern Hebrew , New Hebrew , Israeli Standard Hebrew , Standard Hebrew and so on. Israeli Hebrew exhibits some features of Sephardic Hebrew from its local Jerusalemite tradition but adapts it with numerous neologisms, borrowed terms (often technical) from European languages and adopted terms (often colloquial) from Arabic. The literary and narrative use of Hebrew
16820-533: The period in which they had only been approved under Emergency Use Authorization . After NDA approval, the sponsor must then review and report to the FDA every single patient adverse drug experience it learns of. They must report unexpected serious and fatal adverse drug events within 15 days, and other events on a quarterly basis. The FDA also receives directly adverse drug event reports through its MedWatch program. These reports are called "spontaneous reports" because reporting by consumers and health professionals
16965-525: The phonetic values are instead inspired by the acrophonic principle. The common ancestor of Hebrew and Phoenician is called Canaanite , and was the first to use a Semitic alphabet distinct from that of Egyptian. One ancient document is the famous Moabite Stone , written in the Moabite dialect; the Siloam inscription , found near Jerusalem , is an early example of Hebrew. Less ancient samples of Archaic Hebrew include
17110-656: The potential to realize greater value outside of Perrigo, board okays separation of prescription pharma business on 9 August 2018. The Consumer Self-Care International (CSCI) segment develops, manufactures, markets, and distributes well-known European self-care brands in the natural health and vitamins, cough, cold and allergy, oral care, smoking cessation, personal care and derma-therapeutics and lifestyle categories. Hebrew language Hebrew ( Hebrew alphabet : עִבְרִית , ʿĪvrīt , pronounced [ ʔivˈʁit ] or [ ʕivˈrit ] ; Samaritan script : ࠏࠨࠁࠬࠓࠪࠉࠕ ʿÎbrit )
17255-422: The predicate devices already on the market. Approved requests are for items that are new or substantially different and need to demonstrate "safety and efficacy", for example they may be inspected for safety in case of new toxic hazards. Both aspects need to be proved or provided by the submitter to ensure proper procedures are followed. Cosmetics are regulated by the Center for Food Safety and Applied Nutrition ,
17400-582: The present day. It is perhaps the most important Hebrew manuscript in existence. During the Golden age of Jewish culture in Spain , important work was done by grammarians in explaining the grammar and vocabulary of Biblical Hebrew; much of this was based on the work of the grammarians of Classical Arabic . Important Hebrew grammarians were Judah ben David Hayyuj , Jonah ibn Janah , Abraham ibn Ezra and later (in Provence ), David Kimhi . A great deal of poetry
17545-620: The primary language of use, and to prevent large-scale incorporation of English words into the Hebrew vocabulary. The Academy of the Hebrew Language of the Hebrew University of Jerusalem currently invents about 2,000 new Hebrew words each year for modern words by finding an original Hebrew word that captures the meaning, as an alternative to incorporating more English words into Hebrew vocabulary. The Haifa municipality has banned officials from using English words in official documents, and
17690-566: The regulated industries. Rather, OCI agents pursue and develop cases when individuals and companies commit criminal actions, such as fraudulent claims or knowingly and willfully shipping known adulterated goods in interstate commerce. In many cases, OCI pursues cases involving violations of Title 18 of the United States Code (e.g., conspiracy, false statements, wire fraud, mail fraud), in addition to prohibited acts as defined in Chapter III of
17835-470: The regulatory powers granted to the agency. For example, the FDA regulates almost every facet of prescription drugs, including testing, manufacturing, labeling, advertising, marketing, efficacy, and safety—yet FDA regulation of cosmetics focuses primarily on labeling and safety. The FDA regulates most products with a set of published standards enforced by a modest number of facility inspections. Inspection observations are documented on Form 483 . In June 2018,
17980-657: The rest of the Middle East; and eventually Greek functioned as another international language with the eastern areas of the Roman Empire. William Schniedewind argues that after waning in the Persian period, the religious importance of Hebrew grew in the Hellenistic and Roman periods, and cites epigraphical evidence that Hebrew survived as a vernacular language – though both its grammar and its writing system had been substantially influenced by Aramaic. According to another summary, Greek
18125-448: The safety and labeling of their product. The FDA has a "Dietary Supplement Ingredient Advisory List" that includes ingredients that sometimes appear on dietary supplements but need further evaluation. An ingredient is added to this list when it is excluded from use in a dietary supplement, does not appear to be an approved food additive or recognized as safe, and/or is subjected to the requirement for pre-market notification without having
18270-458: The same branch of the FDA that regulates food. Cosmetic products are not, in general, subject to premarket approval by the FDA unless they make "structure or function claims" that make them into drugs (see Cosmeceutical ). However, all color additives must be specifically FDA approved before manufacturers can include them in cosmetic products sold in the U.S. The FDA regulates cosmetics labeling, and cosmetics that have not been safety tested must bear
18415-485: The southern villages of Judea." In other words, "in terms of dialect geography, at the time of the tannaim Palestine could be divided into the Aramaic-speaking regions of Galilee and Samaria and a smaller area, Judaea, in which Rabbinic Hebrew was used among the descendants of returning exiles." In addition, it has been surmised that Koine Greek was the primary vehicle of communication in coastal cities and among
18560-468: The spoken language of the Russian Jews, should be treated as their only national language, while Hebrew was to be treated as a foreign language. Hebrew books and periodicals ceased to be published and were seized from the libraries, although liturgical texts were still published until the 1930s. Despite numerous protests, a policy of suppression of the teaching of Hebrew operated from the 1930s on. Later in
18705-465: The term "Hebrew" generally render its meaning as roughly "from the other side [of the river/desert]"—i.e., an exonym for the inhabitants of the land of Israel and Judah , perhaps from the perspective of Mesopotamia , Phoenicia or Transjordan (with the river referred to being perhaps the Euphrates , Jordan or Litani ; or maybe the northern Arabian Desert between Babylonia and Canaan ). Compare
18850-456: The transaction valued at $ 750 million. In February 2020, announced that it has reached an agreement to acquire the oral care assets of High Ridge Brands for $ 113 million. In March 2021, Perrigo confirmed it would sell off its generics business to Altaris Capital Partners for $ 1.55 billion. In September, the business announced it would acquire HRA Pharma from investment firms Astorg and Goldman Sachs Asset Management for $ 2.1 billion, and completed
18995-580: The upper class of Jerusalem , while Aramaic was prevalent in the lower class of Jerusalem, but not in the surrounding countryside. After the suppression of the Bar Kokhba revolt in the 2nd century CE, Judaeans were forced to disperse. Many relocated to Galilee, so most remaining native speakers of Hebrew at that last stage would have been found in the north. Many scholars have pointed out that Hebrew continued to be used alongside Aramaic during Second Temple times, not only for religious purposes but also for nationalistic reasons, especially during revolts such as
19140-501: The word Habiru or cognate Assyrian ebru , of identical meaning. One of the earliest references to the language's name as " Ivrit " is found in the prologue to the Book of Sirach , from the 2nd century BCE. The Hebrew Bible does not use the term "Hebrew" in reference to the language of the Hebrew people; its later historiography, in the Book of Kings , refers to it as יְהוּדִית Yehudit " Judahite (language)". Hebrew belongs to
19285-579: The world today; the latter group utilizes the Samaritan dialect as their liturgical tongue. As a non- first language , it is studied mostly by non-Israeli Jews and students in Israel, by archaeologists and linguists specializing in the Middle East and its civilizations , and by theologians in Christian seminaries . The modern English word "Hebrew" is derived from Old French Ebrau , via Latin from
19430-421: Was a spoken language , and Amoraic Hebrew (also called Late Rabbinic Hebrew or Mishnaic Hebrew II), which was a literary language . The earlier section of the Talmud is the Mishnah that was published around 200 CE, although many of the stories take place much earlier, and were written in the earlier Mishnaic dialect. The dialect is also found in certain Dead Sea Scrolls. Mishnaic Hebrew is considered to be one of
19575-453: Was carried out against the Roman Empire by the Jews of Judaea . Aramaic and, to a lesser extent, Greek were already in use as international languages, especially among societal elites and immigrants. Hebrew survived into the medieval period as the language of Jewish liturgy , rabbinic literature , intra-Jewish commerce, and Jewish poetic literature . The first dated book printed in Hebrew
19720-533: Was discovered that several manufacturers had falsified data submitted in seeking FDA authorization to market certain generic drugs. Vitarine Pharmaceuticals of New York, which sought approval of a generic version of the drug Dyazide , a medication for high blood pressure, submitted Dyazide, rather than its generic version, for the FDA tests. In April 1989, the FDA investigated 11 manufacturers for irregularities; and later brought that number up to 13. Dozens of drugs were eventually suspended or recalled by manufacturers. In
19865-534: Was established by the 1902 Biologics Control Act , with additional authority established by the 1944 Public Health Service Act . Along with these Acts, the Federal Food, Drug, and Cosmetic Act applies to all biologic products, as well. Originally, the entity responsible for regulation of biological products resided under the National Institutes of Health ; this authority was transferred to the FDA in 1972. The Center for Devices and Radiological Health (CDRH)
20010-569: Was founded in 1887 in Allegan, Michigan , by Luther and Charles Perrigo, who ran a general store. In 1991 Perrigo had an initial public offering on Nasdaq . In March 2005 the firm acquired Agis Industries Limited (traded as AGIS at the Tel Aviv Stock Exchange ), an Israel-based generic pharmaceuticals company in an $ 850 million transaction. Agis was founded in 1983 by Mori Arkin , who developed his father's small drug import business into
20155-487: Was now a more significant written language than Aramaic within Judaea." This nationalist aspect was further emphasized during periods of conflict, as Hannah Cotton observing in her analysis of legal documents during the Jewish revolts against Rome that "Hebrew became the symbol of Jewish nationalism, of the independent Jewish State." The nationalist use of Hebrew is evidenced in several historical documents and artefacts, including
20300-553: Was published by Abraham Garton in Reggio ( Calabria , Italy) in 1475. With the rise of Zionism in the 19th century, the Hebrew language experienced a full-scale revival as a spoken and literary language. The creation of a modern version of the ancient language was led by Eliezer Ben-Yehuda . Modern Hebrew ( Ivrit ) became the main language of the Yishuv in Palestine , and subsequently
20445-618: Was revived beginning with the Haskalah movement. The first secular periodical in Hebrew, Ha-Me'assef (The Gatherer), was published by maskilim in Königsberg (today's Kaliningrad ) from 1783 onwards. In the mid-19th century, publications of several Eastern European Hebrew-language newspapers (e.g. Hamagid , founded in Ełk in 1856) multiplied. Prominent poets were Hayim Nahman Bialik and Shaul Tchernichovsky ; there were also novels written in
20590-527: Was suppressed. Soviet authorities considered the use of Hebrew "reactionary" since it was associated with Zionism, and the teaching of Hebrew at primary and secondary schools was officially banned by the People's Commissariat for Education as early as 1919, as part of an overall agenda aiming to secularize education (the language itself did not cease to be studied at universities for historical and linguistic purposes ). The official ordinance stated that Yiddish, being
20735-540: Was the language of government, Hebrew the language of prayer, study and religious texts, and Aramaic was the language of legal contracts and trade. There was also a geographic pattern: according to Bernard Spolsky , by the beginning of the Common Era, " Judeo-Aramaic was mainly used in Galilee in the north, Greek was concentrated in the former colonies and around governmental centers, and Hebrew monolingualism continued mainly in
20880-408: Was to a certain extent a pidgin . Near the end of that century the Jewish activist Eliezer Ben-Yehuda , owing to the ideology of the national revival ( שיבת ציון , Shivat Tziyon , later Zionism ), began reviving Hebrew as a modern spoken language. Eventually, as a result of the local movement he created, but more significantly as a result of the new groups of immigrants known under the name of
21025-570: Was written, by poets such as Dunash ben Labrat , Solomon ibn Gabirol , Judah ha-Levi , Moses ibn Ezra and Abraham ibn Ezra , in a "purified" Hebrew based on the work of these grammarians, and in Arabic quantitative or strophic meters. This literary Hebrew was later used by Italian Jewish poets. The need to express scientific and philosophical concepts from Classical Greek and Medieval Arabic motivated Medieval Hebrew to borrow terminology and grammar from these other languages, or to coin equivalent terms from existing Hebrew roots, giving rise to
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