94-425: A biologics license application ( BLA ) is defined by the U.S. Food and Drug Administration (FDA) as follows: The biologics license application is a request for permission to introduce, or deliver for introduction, a biologic product into interstate commerce (21 CFR 601.2). The BLA is regulated under 21 CFR 600 – 680. A BLA is submitted by any legal person or entity who is engaged in manufacture or an applicant for
188-493: A charter to the first Lord Baltimore , the head of the Calvert family. The county's creation was a focus of Thomas S. Wootton who, on August 31, 1776, introduced a measure to form a new county from Frederick County, Maryland to aid area residents in simplifying their business affairs. The measure passed, creating the new political entity of Montgomery County in what was then the colonial -era Province of Maryland . According to
282-720: 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
376-460: 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
470-425: 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
564-745: 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
658-513: 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
752-426: 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
846-402: A family was $ 111,737. Males had a median income of $ 71,841 versus $ 55,431 for females. The per capita income for the county was $ 47,310. About 4.0% of families and 6.0% of the population were below the poverty line , including 7.2% of those under age 18 and 6.3% of those age 65 or over. As of the 2000 United States census , there were 873,058 people living in the county. The racial makeup of
940-464: A license who takes responsibility for compliance with product and establishment standards. Form 356h specifies the requirements for a BLA. This includes: Some biological products are regulated by the Center for Drug Evaluation and Research (CDER) while others are regulated by the Center for Biologics Evaluation and Research (CBER). A BLA is submitted after the investigational new drug (IND) phase, once
1034-432: 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
SECTION 10
#17328865892361128-555: 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
1222-647: 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
1316-582: A public bi-county water and sewer utility in the Washington Suburban Sanitary Commission (WSSC). In October 2020, the Montgomery County Council unanimously passed an ordinance that implemented an LGBTIQ+ bill of rights. Montgomery County is an alcoholic beverage control county. Beer and wine may also be sold in private stores. Until 1964, only three restaurants in the county had liquor licenses to serve liquor by
1410-494: 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
1504-523: 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
1598-425: A single point at Parr's Spring on Parr's Ridge . Montgomery County lies within the northern portions of the humid subtropical climate . It has four distinct seasons, including hot, humid summers and cool winters. Precipitation is fairly evenly distributed throughout the year, with an average of 43 inches (110 cm) of rainfall. Thunderstorms are common during the summer months, and account for
1692-440: 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
1786-553: 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
1880-519: Is a nationally accredited U.S. law enforcement agency and acts as the enforcement arm of the courts in the county. All of its deputy sheriffs are fully certified law enforcement officials with full authority of arrest. The office was created in July 1777 and is the oldest law enforcement agency in Montgomery County. It is headquartered in Rockville, Maryland . It was nationally accredited in 1995,
1974-401: 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
SECTION 20
#17328865892362068-651: 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
2162-650: Is an important business and research center. It is the epicenter for biotechnology in the Mid-Atlantic region. Montgomery County, as third largest biotechnology cluster in the U.S., holds a large cluster and companies of large corporate size within the state. Biomedical research is carried out by institutions including Johns Hopkins University 's Montgomery County Campus (JHU MCC), and the Howard Hughes Medical Institute (HHMI). Federal government agencies in Montgomery County engaged in related work include
2256-547: 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
2350-713: 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,
2444-449: 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
2538-737: 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
2632-696: 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
2726-451: 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
2820-469: The American Revolutionary War . The county's nickname of "MoCo" is derived from " Mo ntgomery Co unty", in use as early as 2001. The county's motto, adopted in 1976, is "Gardez Bien", a French phrase meaning "Watch Well". The county's motto is also the motto of its namesake's family. Prior to 1688, the first tract of land in what is now Montgomery County was granted by Charles I in
2914-623: 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
Biologics license application - Misplaced Pages Continue
3008-890: The Food and Drug Administration (FDA), the National Institutes of Health (NIH), the Uniformed Services University of the Health Sciences (USUHS), and the Walter Reed Army Institute of Research . Many large firms are based in the county, including Coventry Health Care , Lockheed Martin , Marriott International , Host Hotels & Resorts , Travel Channel , Ritz-Carlton , Robert Louis Johnson Companies ( RLJ Companies ), Choice Hotels , MedImmune , TV One , BAE Systems Inc. , Hughes Network Systems and GEICO . Other U.S. federal government agencies based in
3102-519: The U.S. Census Bureau , the county has a total area of 507 square miles (1,310 km ), of which 491 square miles (1,270 km ) is land and 16 square miles (41 km ) (3.1%) is water. Montgomery County lies entirely inside the Piedmont plateau . The topography is generally rolling. Elevations range from a low of near sea level along the Potomac River to about 875 feet in the northernmost portion of
3196-469: 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 . Montgomery County, Maryland Montgomery County is the most populous county in
3290-639: 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
3384-404: The tenth-highest median household income in the United States, and the second highest in the state after Howard County as of 2011. The median household income in 2007 was $ 89,284 and the median family income was $ 106,093. Males had a median income of $ 66,415 versus $ 52,134 for females. The per capita income for the county was $ 43,073. About 3.3% of families and 4.6% of the population were below
3478-606: 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)
3572-406: 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
3666-432: The 2009–2010 season. Since the 1970s, the county has had in place a Moderately Priced Dwelling Unit (MPDU) zoning plan that requires developers to include affordable housing in any new residential developments that they construct in the county. The goal is to create socioeconomically mixed neighborhoods and schools so the rich and poor are not isolated in separate parts of the county. Developers who provide for more than
3760-696: The Beltway and I-270 , and they assist county and city police in investigation of some major crimes. Montgomery County has a budget of $ 2.3 billion. Approximately $ 1.48 billion are invested in Montgomery County Public Schools and $ 128 million in Montgomery College . Montgomery and Prince George's counties share a bi-county planning and parks agency in the Maryland-National Capital Park and Planning Commission (M-NCPPC) and
3854-501: 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
Biologics license application - Misplaced Pages Continue
3948-622: 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
4042-636: 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,
4136-703: 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,
4230-581: 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
4324-871: 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
4418-623: 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),
4512-635: The Maryland Constitutional Convention, to create lower Frederick County as Montgomery County. The name, Montgomery County, along with the founding of Washington County, Maryland, after George Washington , was the first time in American history that counties and provinces in the Thirteen Colonies were not named after British referents. The name use of Montgomery and Washington County were seen as further defiance to Great Britain during
4606-464: The U.S. state of Maryland . As of the 2020 census , the county's population was 1,062,061, increasing by 9.3% from 2010. The county seat is Rockville , and Germantown is the most populous place in the county. The county is adjoined to Washington, D.C. , the nation's capital, and is part of the Washington metropolitan area and the Washington–Baltimore combined statistical area . Most of
4700-477: 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
4794-407: The age of 18 living with them, 53.4% were married couples living together, 11.3% had a female householder with no husband present, 31.4% were non-families, and 25.0% of all households were made up of individuals. The average household size was 2.70 and the average family size was 3.22. The median age was 38.5 years. The median income for a household in the county was $ 93,373 and the median income for
SECTION 50
#17328865892364888-809: 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
4982-468: 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
5076-800: The biologic. After approval, annual reports, reports on adverse events, manufacturing changes, and labeling changes must be submitted. Food and Drug Administration 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
5170-473: 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
5264-527: The clinical investigations are completed. If the Form 356h is missing information, the FDA will reply within 74 days. A BLA asserts that the product is "safe, pure, and potent", the manufacturing facilities are inspectable, and each package of the product bears the license number. Statutory standards for BLA approval are largely the same as those for New Drug Application approval. According to 21 CFR 600.3 , FDA interprets "potency" to include effectiveness of
5358-502: 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
5452-568: The council are Democrats. The council meets weekly at the county seat of Rockville—the 6th Floor of the Stella B. Werner Council Office Building. The members of the County Council as of 2023 are: The most recent Republican serving on the Montgomery County Council, Howard A. Denis of District 1 (Potomac/Bethesda), lost re-election in 2006. Since then, all Council members have been Democrats. The Montgomery County Police Department (MCPD) provides
5546-418: The county has several U.S. government offices, scientific research and learning centers, and business campuses. The Maryland state legislature named Montgomery County after Richard Montgomery ; the county was created from lands that had at one point or another been part of Frederick County . On September 6, 1776, Thomas Sprigg Wootton from Rockville, Maryland, introduced legislation, while serving at
5640-619: The county include the National Oceanic and Atmospheric Administration (NOAA), Nuclear Regulatory Commission (NRC), U.S. Department of Energy (DOE), the National Institute of Standards and Technology (NIST), the Walter Reed National Military Medical Center (WRNMMC), and the U.S. Consumer Product Safety Commission (CPSC). Downtown Bethesda and Silver Spring are the largest urban business hubs in
5734-404: The county north of Damascus. Relief between valley bottoms and hilltops is several hundred feet. Earthquakes are rare; the most recent one, on June 24, 2024, had a 1.8 magnitude and was centered near Spencerville, Maryland . When Montgomery County was created in 1776, its boundaries were defined as "beginning at the east side of the mouth of Rock Creek on Potomac river [sic], and running with
SECTION 60
#17328865892365828-561: The county was 65.0% white, 15.1% Black or African American, 11.3% Asian, 0.3% American Indian, 0.1% Pacific islander, 5.0% from other races, and 3.5% from two or more races. Those of Hispanic or Latino origin made up 11.5% of the population. There were 324,565 households, of which 35% had children under the age of 18 living with them, 55.2% were married couples living together, 10.5% had a female householder with no husband present, and 30.9% were non-families. Of all households, 24.4% were made up of individuals, and 7.7% had someone living alone who
5922-435: The county's population. Over 52,000 people of Salvadoran descent lived in Montgomery County, with Salvadoran Americans comprising approximately 32% of the county's Hispanic and Latino population. People of South American descent make up 3.8% of the county, with Peruvian Americans being the largest South American community, constituting 1.2% of the county's population. Of the 357,086 households, 35.7% had children under
6016-506: The county's residents are affiliated with a religion . Montgomery County was named the most religiously diverse county in the United States in 2023 by the Public Religion Research Institute 's census. Counties were given a diversity index between 0 and 1, with 0 signifying no diversity, and 1 signifying complete diversity. Montgomery County earned a .886, higher than the national average of .615. Montgomery County has
6110-531: The county's residents live in Silver Spring , Bethesda , Germantown , and the incorporated cities of Rockville and Gaithersburg . The average household income in Montgomery County is the 20th-highest among U.S. counties as of 2020. The county has the highest percentage (29.2%) of residents over 25 years of age who hold post-graduate degrees . Like other counties in the Washington metropolitan area,
6204-470: The county; combined, they rival many major city cores. According to the county's comprehensive annual financial reports , the top employers by number of employees in the county are the following. "NR" indicates the employer was not ranked among the top ten employers that year. Montgomery County was granted a charter form of government in 1948. The present County Executive / County Council form of government of Montgomery County dates to November 1968 when
6298-466: 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
6392-416: 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
6486-678: 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
6580-648: 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
6674-436: 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,
6768-591: The first county sheriff's office in Maryland to be so. The MCSO has authorized over 165 employees consisting of sworn law enforcement officers and civilian support staff. The office is headed by the sheriff, who has been elected every four years since the 1920s. The current Sheriff is Maxwell C. Uy (D), elected in 2022. Uy is the 62nd Sheriff and the first Asian American to hold that office. Several cities including Rockville and Gaithersburg maintain their own police departments to complement MCPD. Maryland State Police patrol
6862-469: The fiscal year ending June 30, 2021. The office of the county executive was established in 1970. The first executive was James P. Gleason. The current executive is Marc Elrich, who was sworn in for his first term on December 3, 2018. The County Council is the legislative branch of Montgomery County. It has eleven members who serve four-year terms. All are elected at the same time by the voters of Montgomery County. As of January 2023, all 11 members on
6956-738: The full spectrum of policing services to the entire county. It was founded in 1922 and is headquartered in Gaithersburg, Maryland . It consists of around 1,300 sworn officers and 650 support personnel, split into 6 districts throughout the county. The department also provides assistance to other nearby departments, such as the Metropolitan Police Department of the District of Columbia and the Prince George's County Police Department , if requested. The Montgomery County Sheriff's Office (MCSO)
7050-545: 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)
7144-518: The largest Jewish population in the state of Maryland, accounting for 45% of Maryland Jews. According to the Berman Jewish DataBank , Montgomery County has a Jewish population of 105,400 people, around 10% of the county's population. The Washington metropolitan area , with 295,500 Jews, has become the third-largest Jewish population in the United States. As of 2020, Montgomery County is home to 776 religious congregations. Montgomery County
7238-749: The majority of the average 35 days with thunder per year. Heavy precipitation is most common in summer thunderstorms, but drought periods are more likely during these months because summer precipitation is more variable than winter. The mean annual temperature is 55 °F (13 °C). The average summer (June–July–August) afternoon maximum is about 85 °F (29 °C) while the morning minimums average 66 °F (19 °C). In winter (December–January–February), these averages are 44 °F (7 °C) and 28 °F (−2 °C). Extreme heat waves can raise readings to around and slightly above 100 °F (38 °C), and arctic blasts can drop lows to −10 °F (−23 °C) to 0 °F (−18 °C). For Rockville ,
7332-420: The minimum amount of MPDUs are rewarded with permission to increase the density of their developments, which allows them to build more housing and generate more revenue . Montgomery County was one of the first counties in the U.S. to adopt such a plan, but many other areas have since followed suit. Montgomery County is by far one of the most ethnically and culturally diverse counties in the United States; four of
7426-455: The only minority-majority state on the East Coast. As of the 2010 United States census , there were 971,777 people, 357,086 households, and 244,898 families living in the county. The population density was 1,978.2 inhabitants per square mile (763.8/km ). There were 375,905 housing units at an average density of 765.2 per square mile (295.4/km ). The racial makeup of the county
7520-533: 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
7614-478: The poverty line, including 4.6% of those under age 18 and 4.6% of those age 65 or over. Of Montgomery County's residents, 14% are Catholic , 5% are Baptist , 3% are Methodist , 1% are Presbyterian , 1% are Episcopalian , 1% are part of the Latter Day Saint movement , 1% are Lutheran , 6% are of another Christian faith, 3% are Jewish , 1% follows Islam , and 1% are of an eastern faith . Overall, 41% of
7708-422: 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 ,
7802-440: The record high is 105 °F (41 °C) in 1954, while the record low is −13 °F (−25 °C). Lower elevations in the south, such as Silver Spring , receive an average of 17.5 inches (44 cm) of snowfall per year. Higher elevations in the north, such as Damascus , receive an average of 21.3 inches (54 cm) of snowfall per year. During a particularly snowy winter, Damascus received 79 inches (200 cm) during
7896-566: 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
7990-470: 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,
8084-448: 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
8178-577: The said river to the mouth of Monocacy , then with a straight line to Par's spring, from thence with the lines of the county to the beginning". The county's boundary forms a sliver of land at the far northern tip of the county that is several miles long and averages less than 200 yards wide. In fact, a single house on Lakeview Drive and its yard is sectioned by this sliver into three portions, each separately contained within Montgomery, Frederick and Howard counties. These jurisdictions and Carroll County meet at
8272-458: 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
8366-478: The ten most culturally diverse cities and towns in the U.S. are in Montgomery County: Gaithersburg , ranking second; Germantown , ranking third; Silver Spring , ranking fourth; and Rockville , ranking ninth. Gaithersburg, Germantown, and Silver Spring all rank as more culturally diverse than New York City , San Jose , and Oakland . Maryland overall is one of six minority-majority states, and
8460-406: The voters changed the form of government from a County Commission / County Manager system, as provided in the original 1948 home rule Charter. The County Commission/County Manager system was seen as inadequate for the growing population of the county who wanted more services assistance and accountability from the government. The Montgomery County government had a surplus of $ 654 million for
8554-542: Was 57.5% White, 17.2% Black or African American, 13.9% Asian, 0.4% American Indian, 0.1% Pacific islander, 7.0% from other races, and 4.0% from two or more races. Those of Hispanic or Latino origin made up 17.0% of the population. In terms of ancestry, 10.7% were German , 9.6% were Irish , 7.9% were English , 4.9% were Italian , 3.5% were Russian , 3.1% were Polish , 2.9% were American and 2% were French . People of Central American descent made up 8.1% of Montgomery County, with Salvadoran Americans constituting 5.4% of
8648-522: Was 65 years of age or older. The average household size was 2.66 and the average family size was 3.19. 25.4% of the population was under the age of 18, 6.9% from 18 to 24, 32.3% from 25 to 44, 24.2% from 45 to 64, and 11.2% who were 65 years of age or older. The median age was 37 years. For every 100 females, there were 92.1 males. For every 100 females age 18 and over, there were 88.1 males. In 2000, there were 334,632 housing units at an average density of 675 per square mile (261/km ). Montgomery County has
8742-533: 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
8836-473: 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)
#235764