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81-543: The Barkat Pharmaceutical Group has established as the first specialized drug and pharmaceutical research center in Iran, also it has been developed by constructing advanced pharmaceutical factories, called Barkat Pharmaceutical Town. The Barkat group complies with all common pharmaceutical standards such as the FDA , WHO , EMEA . " Cell therapy ", production of "peptide medications", "research, development and processing of medicinal plants,"

162-720: 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

243-460: 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

324-433: A Danish pharmaceutical company in 2015 and a contract of $ 15 million with a Swiss company in 2016 were among the most important of these contracts. This holding, which has more than 500,000 shareholders, is considered as the second pharmaceutical holding of the country in the pharmaceutical industry. Barkat Pharmaceutical Group Company (Public Joint Stock Company) was established with more than 20 subsidiaries in 2010 based on

405-425: 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

486-745: 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

567-624: A cell factory with participation of the Royan Institute In the field of Cell Therapy and an international pharmacy university in PhD 's degree with the goal of providing the required specialized personnel, researchers and healthcare technologists. According to "Hamid Reza Jamshidi", the managing director of Barkat Pharmaceutical Group, 12% of the drugs of the Islamic Republic of Iran are produced in this pharmaceutical group. Mohammadi, director of

648-513: 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

729-426: 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

810-556: A degree in physics. He was active in revolutionary groups prior to the Iranian Revolution and once was wounded by the forces of the Shah Mohammad Reza Pahlavi . He later received a PhD from Islamic Azad University, Science and Research Branch, Tehran in industrial management. He is married to Manijeh Jahangiri and has four children, Hossein, Hesam, Faezeh and Hoda. Jahangiri began his political career following

891-432: 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

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972-555: 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

1053-647: 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

1134-494: 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

1215-523: 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

1296-562: A subsidiary of Barkat Pharmaceutical Group. Clinical trials began in December 2020 and the vaccine received emergency use authorization on 13 June 2021. According to the Execution of Imam Khomeini's Order , about 8 million doses of COVIran Barekat have been produced up to 30 August 2021. According to British medical journal, the BMJ in 2023, this Iranian vaccine has 100% efficacy against related death at 90 days. The Barkat Pharmaceutical Industrial Town

1377-440: 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

1458-553: 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

1539-401: 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

1620-651: 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

1701-491: Is a specialized pharmaceutical and research Town Which was registered as the first pharmaceutical industrial park in the country and the country's first Special Economic Pharmaceutical zone . The site is located in Savojbolagh with area of 200 hectares, Alborz province , 60 km away from Tehran and designed by international consultants and based on the latest standards of the world's pharmaceutical-industrial cities. One of

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1782-474: Is a subsidiary of the Barkat Pharmaceutical Group and is run by Cell Tech Pharmed, a company established in 2014 to work on stem cells, biotechnology , nanotechnology and pharmaceuticals . It also manufactures products including Monocell, Ricollersal, Rhinooderm cell, etc. which are used to treat various cardiovascular , skin and skeletal diseases . In order to provide anticancer drugs in

1863-574: Is also possible to invest over $ 5 billion, in full capacity, in the Barkat Pharmaceutical Town. The Barkat Pharmaceutical Group has signed investment contracts with 30 and domestic medical and healthcare companies in the healthcare industry. So far in order to produce medicines, there are three contracts between pharmaceutical companies from Switzerland , the UK and Denmark for producing medicines. The direct investment contract of €70 million with

1944-584: Is an Iranian politician who served as the sixth first vice president from 2013 until 2021 in Hassan Rouhani's government . Jahangiri was the minister of industries and mines from 1997 to 2005 under President Mohammad Khatami . Before that, he was the governor of Isfahan Province . He was also a member of Parliament for two terms. Jahangiri was born on 21 January 1958 in Sirjan County , Kerman Province . He graduated from University of Kerman with

2025-547: 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

2106-713: 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,

2187-449: 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

2268-737: 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

2349-696: 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

2430-451: 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

2511-465: The 2013 presidential election but he withdrew in favor of Akbar Hashemi Rafsanjani and then became Rafsanjani's campaign manager. He was a co-founder of Executives of Construction Party and served as its secretary general from 2006 to 2010. He was also a member of Mir-Hossein Mousavi 's presidential campaign in the 2009 presidential election . On 23 July 2013, it was reported that Jahangiri would be

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2592-692: The COVID-19 pandemic became known to have spread to Iran , the IranWire website reported that Jahangiri had been infected with SARS-CoV-2 , the virus that causes coronavirus disease 2019 . However, there was no immediate confirmation from Iranian officials. On 11 March, his infection was confirmed by semi-official Fars News Agency . On 15 March, his office announced that he "tested negative for coronavirus and since he has fully recovered, he returned to his office and resumed his job". He has four other brothers named Ebrahim, Yaqub, Mohammad, and Mehdi, among them Mehdi

2673-671: 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

2754-560: The United States Department of Agriculture . The FDA regulates tobacco products with authority established by the 2009 Family Smoking Prevention and Tobacco Control Act . This Act requires color warnings on cigarette packages and printed advertising, and text warnings from the U.S. Surgeon General . Eshaq Jahangiri Eshaq Jahangiri Kouhshahi ( Persian : ‌اسحاق جهانگیری کوهشاهی , pronounced [esˈhɒːɢ dʒæhɒ:ŋˈgi:ɾi: ku:hʃɒ:ˈhi:] ; born 21 January 1958)

2835-639: 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

2916-606: 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)

2997-406: 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

3078-654: The Alborz Pharmaceutical Company, said about a $ 2 billion investment in the production of herbal medicines by the Barakat Foundation . To this end, the specialized zone of medicine and health technologies is under construction of the Barkat Industrial Pharmaceutical Town. He also identified the production of natural health products as the new missions of Barakat Foundation, which follows the production of herbal medicines by launching

3159-634: The Barkat Pharmaceutical Group is Hamid Reza Jamshidi, who has a Ph.D. degree in Pharmacy from the University of Isfahan and a Ph.D. in Neuroscience from the University of Alberta , Canada . One of the activities of the Barkat Pharmaceutical Group is the building of a 200 hectare pharmaceutical town. Also, " cell therapy " by producing five products for the treatment of skin and heart disease and knee arthritis , production of " peptide medications " using in

3240-501: 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

3321-622: 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

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3402-687: 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,

3483-703: 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,

3564-581: 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

3645-871: 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

3726-491: The Group of Pharmaceutical Materials and Products. By this date, 50% of the company's shareholders were natural people . According to Baqerinezhad, the company's research and development deputy, 800 billion tomans is defined as investment, for the second five-year development plan of the company. Also, in order to realize the support of the private sector , a Research and Development Fund of Bold investing ( VC ) has been launched. It

3807-811: The Iranian Interior Architecture Award. FDA The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of 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

3888-638: The Iranian revolution. He became deputy head of the agriculture department in Kerman in July 1980. Then, he was appointed its head in 1982. He was elected to the Iranian Parliament in 1984 election . He was also reelected in next election . He was appointed governor of Isfahan on 1 September 1992 by Akbar Hashemi Rafsanjani to replace with Gholamhossein Karbaschi . He held the position until 20 August 1997 when he

3969-623: 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), 

4050-464: The Research and Technology Fund. The Medicinal Herbs Garden Museum, located in Barkat Pharmaceutical Town, is a place to introduce and present the achievements of medicine and Medicinal plants in Iran. The site was opened in 2006 on an area of 10,000 square meters. The Garden Museum presents the diversity, plurality, benefits and Properties of medicinal plants, the history of research on medicinal plants,

4131-477: 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

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4212-757: 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

4293-442: The analysis and foresight of Iran's pharmaceutical industry and with the aim of meeting the needs of society, under the name of "Tadbir New Pharmaceutical Technologies Company". The company, as a knowledge-based economic complex, has chosen its approach to focus on health products. Barkat Pharmaceutical Group operates with 25 companies in its subsidiary, all of which are active in the drug supply chain. The current managing director of

4374-468: 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

4455-473: 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

4536-721: The community are the main indicators of the acceptance of companies in the Barkat Industrial Pharmaceutical Town. According to Najafi , Governor of Alborz, this site has presented more than 7,000 direct job opportunities. In the Special Economic Pharmaceutical zone of Barkat, the appropriate space is anticipated for the deployment of pharmaceutical manufacturing companies in the fields of research and development and incubators , knowledge-based , cell therapy , biotechnology , gene therapy , blood and plasma refinement, vaccine, and also pharmaceutical companies and central warehouses. The Barkat Pharmaceutical Town also includes

4617-502: 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

4698-423: The country and also exported to 10 other countries. Sobhan Oncology Company produces anticancer drugs in the form of oral and injectable drugs . Also using nanotechnology in producing anticancer improves drug delivery and increases efficacy on cancerous tissue and reduces the side effects of treatment. COVIran Barekat is Iran's first domestic COVID-19 vaccine . It's made by Shifa Pharmed Industrial Group,

4779-540: The country, "Sobhan Chemotherapy products Company" (Sobhan Oncology Co, under the supervision of the Barkat Pharmaceutical Group ) was set up on 2002, and launched in February 2010 with global standards. The main activity of the company is the production of drugs for the treatment of cancer patients. It is the first anti-cancer product manufacturer in the Middle East . The company's pharmaceutical products are distributed around

4860-466: The creation of the "Museum of Iranian-Islamic Medicine" as well as "Solids and Semi-Solids" projects are the main activities of the Group. On 4 December 2016, the company was listed as Tehran Stock Exchange's 506th company after receiving 340 billion Rials in funding. On 5 February 2017, 340 million shares of the Barkat Pharmaceutical Group were first Released on the Tehran Stock Exchange in

4941-466: 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

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5022-416: 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

5103-678: 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

5184-648: 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

5265-436: 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,

5346-500: The history of medicine, the capacities of Iranian medicinal plants and traditional medicine in Iran for the upcoming scientific movement. For this purpose, various sections have been created to display medical science issues such as timelines, doctors, hospitals, small instruments, showrooms, libraries, large instruments, Fragrances and Medicinal Plants. on 2016, the project won the title of the Department of Public-Cultural Building group in

5427-545: 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)

5508-510: The main goal for the establishment of the Barkat Pharmaceutical Industrial Park is attracting $ 2 billion to finance a wide range of medical and pharmaceutical needs, including bio drugs, medical equipment , laboratory diagnostic kits and pharmaceutical packaging materials . The pharmaceutical company's products are supplied locally and exported abroad. Being High tech and ability to provide new services and innovations to

5589-487: The next First Vice President and would be appointed by Rouhani after his inauguration. On 29 July, it was confirmed officially, pending his appointment for the post in the inauguration day. He was formally appointed on 4 August by Rouhani as his first vice president, replacing Mohammad Reza Rahimi . In April 2017, it was announced the Jahangiri would register as a candidate for the 2017 Iranian presidential elections . He

5670-533: 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

5751-422: 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 ,

5832-581: The production of various pharmaceutical products, are among other activities of the Barkat Pharmaceutical Group. On May 15, 2018, the first factory for the production of stem cells in Western Asia (Cell Tech Pharmed) was inaugurated with the presence of Minister of Health and Medical Education Hassan Ghazizadeh Hashemi , and the First Vice President of Iran Eshaq Jahangiri The factory, set up by Barkat Pharmaceutical Company and Royan Institute ,

5913-566: 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

5994-470: 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,

6075-448: 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

6156-458: 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

6237-423: The treatment of high-dose diseases such as Multiple sclerosis , blood diseases and cancer , " Research and development and processing of medicinal plants ", in order to use domestic capacities and prevent the sale of raw materials and entry into world markets, the "Museum of Iranian-Islamic medicine" to show the role of Iranian scientists in medicine , as well as the "Solids and Semi-Solids" projects to increase

6318-533: 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

6399-534: 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)

6480-473: Was nominated by Mohammad Khatami as the minister of mines and metals and was confirmed by the Parliament. His portfolio was later changed to the minister of industries and mines and he held that position until President Ahmadinejad 's cabinet took over in 2005. In 2008, it was rumored that Jahangiri would run for a seat in the Parliament but he denied it. Jahangiri was a potential reformist 's candidate in

6561-498: Was successfully vetted and approved by the Guardian Council on 20 April 2017 and officially became a presidential candidate. Many viewed his decision to run for the presidency as a tactical decision to support Rouhani throughout the debates and then withdraw before the voting commenced. He withdrew on 16 May 2017. Later, Hassan Rouhani won the election and Jahangiri was reappointed as first vice president. On 4 March 2020, after

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