92-480: A Humanitarian Device Exemption is an approval process provided by the United States Food and Drug Administration allowing a medical device to be marketed without requiring evidence of effectiveness . The FDA calls a device approved in this manner a "Humanitarian Use Device" (HUD). To qualify, the device must be intended to benefit patients with a rare disease or condition (i.e. fewer than 8,000 people in
184-720: 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
276-460: 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
368-425: 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
460-745: 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
552-513: 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
644-426: 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
736-432: 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
828-555: 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
920-647: 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
1012-555: A presence in the area include Fortrea , IQVIA , Charles River Laboratories , and ICON plc . The area's medical research is driven by government and non-profit health institutions, such as the Howard Hughes Medical Institute , J. Craig Venter Institute , and the National Institutes of Health . Local consumer goods companies include Nestle USA and Mars, Incorporated . Many defense contractors are based in
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#17329098039201104-494: 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
1196-523: 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
1288-457: A significant biotechnology industry; companies with a major presence in the region as of 2011 include Merck , Pfizer , Human Genome Sciences , Martek Biosciences , and Qiagen . Additionally, many biotechnology companies such as United Therapeutics , Novavax , Emergent BioSolutions , Parabon NanoLabs and MedImmune have headquarters in the region. The area is also home to branch offices of many contract research organizations . Firms with
1380-623: A significant shuffling of military, civilian, and defense contractor employees in the Washington metropolitan area. The largest individual site impacts of the time are as follows: BRAC 2005 was the largest infrastructure expansion by the Army Corps of Engineers since World War II , resulting in the Mark Center , tallest building they have ever constructed, as well as National Geospatial-Intelligence Agency Campus East, which at 2.4 million square feet
1472-440: 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
1564-553: 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
1656-401: 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
1748-651: 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
1840-503: Is a significant industry in the Washington metropolitan region. In 2015, more than 74,000 tourism-sector jobs existed in the District of Columbia, a record-setting 19.3 million domestic tourists visited the city, and domestic and international tourists combined spent $ 7.1 billion. The convention industry is also significant; in 2016, D.C. hosted fifteen "city-wide conventions" with an estimated total economic impact of $ 277.9 million. Tourism
1932-637: Is also significant outside the District of Columbia; in 2015, a record-setting $ 3.06 billion in tourism spending was reported in Arlington , Virginia, and $ 2.9 billion in Fairfax County , Virginia. A 2016 National Park Service report estimated that there were 56 million visitors to national parks in the National Capital Region, sustaining 16,917 and generating close to $ 1.6 billion in economy impact. The 2005 Base Realignment and Closure resulted in
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#17329098039202024-547: 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
2116-480: Is included – and 23rd in the entire United States. 12.2% of Northern Virginia's 881,136 households, 8.5% of suburban Maryland's 799,300 households, and 8.2% of Washington's 249,805 households have an annual income in excess of $ 200,000, compared to 3.7% nationally. According to a report by the American Human Development Project , women in the Washington metropolitan area are ranked as having
2208-474: Is less than half the size of L.A., but both cities have around 100,000 Ph.D.'s." The Washington metropolitan area has held the top spot in the American College of Sports Medicine 's annual American Fitness Index ranking of the United States' 50 most populous metropolitan areas for two years running. The report cites, among other things, the high average fitness level and healthy eating habits of residents,
2300-713: 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,
2392-486: Is made up of periodicals such as National Affairs , those by The Slate Group , Foreign Policy , National Geographic , The American Prospect , and those by Atlantic Media , including The Atlantic . There are also many smaller regional publications present, such as The Washington Diplomat , The Hill , Hill Rag , Roll Call , Washington City Paper and the Washington Examiner . Anchored by
2484-454: Is surrounded by Interstate 495 with the locations inside of it referred to as Inside the Beltway . Washington, D.C., which is at the center of the area, is sometimes referred to as the District because of its status as a federal district, which makes it not part of any state. The Virginian portion of the region is known as Northern Virginia . The Maryland portion of the region is sometimes called
2576-449: 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
2668-737: 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
2760-847: Is the largest building the Corps have constructed since the Pentagon . "WMATA"-indicated systems are run by Washington Metropolitan Area Transit Authority and always accept Washington Metro fare cards; others may or may not. Listing of the professional sports teams in the Washington metropolitan area: The Washington metropolitan area is home to DCTV , USA Today , C-SPAN , PBS , NPR , Politico , BET , TV One and Discovery Communications . The two main newspapers are The Washington Post and The Washington Times . Local television channels include WRC-TV 4 (NBC), WTTG 5 (FOX), WJLA 7 (ABC), WUSA 9 (CBS), WDCA 20 (MyNetworkTV), WETA-TV 26 (PBS), WDCW 50 (CW), and WPXW 66 ( Ion ). WJLA 24/7 News
2852-413: Is the third-largest combined statistical area in the country. The Washington metropolitan area is one of the most educated and affluent metropolitan areas in the U.S. The metro area anchors the southern end of the densely populated Northeast megalopolis with an estimated total population of 6,304,975 as of 2023 estimates, making it the seventh-most populous metropolitan area in the nation, as well as
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2944-696: 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
3036-451: 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
3128-671: 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
3220-619: The D.C. area , Greater Washington , the National Capital Region , or locally as the DMV (short for District of Columbia , Maryland , and Virginia ), is the metropolitan area centered around Washington, D.C. , the federal capital of the United States . The metropolitan area includes all of Washington, D.C. and parts of Maryland, Virginia, and West Virginia . It is part of the larger Washington–Baltimore combined statistical area , which
3312-579: 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
3404-653: The Dulles Technology Corridor , the telecommunications and tech industry in DC spans a diverse range of players across internet infrastructure, broadcasting, satellite communications, and datacenters. Firms headquartered in the area include Cogent Communications , GTT Communications , Hughes Network Systems , iCore Networks , Iridium Communications , Intelsat , Ligado Networks , NII Holdings , Oceus Networks , OneWeb , Tegna Inc. , Transaction Network Services , Verisign , WorldCell , and XO Communications . Tourism
3496-447: The U.S. Senate , and the U.S. House of Representatives . MWCOG provides a forum for discussion and the development of regional responses to issues regarding the environment, transportation, public safety, homeland security, affordable housing, community planning, and economic development. The National Capital Region Transportation Planning Board , a component of MWCOG, is the federally designated metropolitan planning organization for
3588-521: 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 . Washington metropolitan area Washington–Arlington–Alexandria MSA The Washington metropolitan area , also referred to as
3680-793: The United States Institute of Peace , and the John F. Kennedy Center for the Performing Arts representing nearly 300,000+ students. The consortium facilitates course cross registration between all member universities, and universalizes library access across some of its member universities through the Washington Research Library Consortium . It additionally offers joint procurement programs, joint academic initiatives, and campus public safety training. Formed in 1967 as an interstate compact between Maryland , Virginia, and
3772-639: 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
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3864-606: 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)
3956-406: 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
4048-628: The Bureau of Labor Statistics, Claritas Inc., and other sources. The Washington metropolitan area was ranked as the second best High-Tech Center in a statistical analysis of the top 100 Metropolitan areas in the United States by American City Business Journals in May 2009, behind the Silicon Valley and ahead of the Boston metropolitan area . Fueling the metropolitan area's ranking was the reported 241,264 tech jobs in
4140-591: The District of Columbia , the WMATA is a tri-jurisdictional government agency with a board composed of representatives from Maryland, Virginia, the District of Columbia, and the United States Federal government that operates transit services in the Washington Metropolitan Area. The Metropolitan Washington Airports Authority (MWAA) is a multi-jurisdictional independent airport authority, created with
4232-501: 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
4324-622: 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
4416-687: 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,
4508-703: 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,
4600-581: 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
4692-871: 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
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#17329098039204784-623: 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),
4876-645: The Maryland-National Capital Region by local authorities but rarely by the general public. The U.S. Census Bureau divides the Washington metropolitan statistical area into three (formerly two) metropolitan divisions: Founded in 1957, the Metropolitan Washington Council of Governments (MWCOG) is a regional organization of 21 Washington-area local governments, as well as area members of the Maryland and Virginia state legislatures,
4968-462: The US annually). The applicant must also show that there is no other way that the device could be brought to market, and that there is no comparable device already available. This article related to medical equipment is a stub . You can help Misplaced Pages by expanding it . Food and Drug Administration The United States Food and Drug Administration ( FDA or US FDA ) is a federal agency of
5060-477: 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
5152-432: The Washington metropolitan area. The metropolitan area includes the following principal cities (not all of which are incorporated as cities; one, Arlington, actually is a county, while Bethesda and Reston are unincorporated census-designated places). The Washington metropolitan area is considered a Democratic stronghold. The last Republican to win it was Richard Nixon in his 1972 landslide reelection. Since Bill Clinton
5244-550: The Washington-Arlington-Alexandria, DC-VA-MD-WV (MSA) was $ 561,027,941,000. Changes in house prices for the Washington metropolitan area are publicly tracked on a regular basis using the Case–Shiller index ; the statistic is published by Standard & Poor's and is also a component of S&P's 10-city composite index of the value of the U.S. residential real estate market. McLean ZIP code 22102 had
5336-757: 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
5428-468: 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
5520-473: 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
5612-683: The consent of the United States Congress and the legislature of Virginia to oversee management, operations, and capital development of Ronald Reagan Washington National Airport and Washington Dulles International Airport . Founded in 1889, the Greater Washington Board of Trade is a network of regional businesses that work to advance the culture, economy, and resiliency of the Washington metropolitan area. The Cultural Alliance of Greater Washington (CAGW) works to increase appreciation, support, and resources for arts and culture in
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#17329098039205704-502: 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
5796-466: 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
5888-416: 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
5980-678: 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
6072-648: 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
6164-417: The federal city of Washington, D.C., the county (and census-designated place ) of Arlington , and the independent city of Alexandria . The Office of Management and Budget also includes the metropolitan statistical area as part of the larger Baltimore–Washington metropolitan area , which has a population of 9,546,579 as of the 2014 Census Estimate. The Washington, D.C., Maryland, and Virginia portions of
6256-436: 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,
6348-611: The highest income and educational attainment among the 25 most populous metropolitan areas in the nation, while Asian American women in the region had the highest life expectancy, at 92.3 years. The Washington metropolitan area has the largest science and engineering work force of any metropolitan area in the nation in 2006 according to the Greater Washington Initiative at 324,530, ahead of the combined San Francisco Bay Area work force of 214,500, and Chicago metropolitan area at 203,090, citing data from U.S. Census Bureau,
6440-473: The highest median home prices among ZIP codes within the Washington metropolitan area as of 2013. The economy of the Washington metropolitan region is characterized by significant wealth disparities , which were heightened by the Great Recession and the 2007–09 housing crisis , which adversely affected black and Hispanic households more than other households. A 2016 Urban Institute report found that
6532-568: The highest-educated metropolitan area in the nation for four decades. As of the 2006–2008 American Community Survey , the three most educated places with 200,000 people or more in Washington–Arlington–Alexandria by bachelor's degree attainment (population 25 and over) are Arlington , Virginia (68.0%), Fairfax County , Virginia (58.8%), and Montgomery County , Maryland (56.4%). Forbes magazine stated in its 2008 "America's Best- And Worst-Educated Cities" report: "The D.C. area
6624-473: The hospitality and hotel industries. Major companies with headquarters in the region include Marriott International , The Ritz-Carlton Hotel Company , Hilton Worldwide , Park Hotels and Resorts , Choice Hotels , Host Hotels and Resorts , and HMSHost . The media industry is a significant portion of metropolitan Washington's economy. According to the Bureau of Labor Statistics, the Washington DC region has
6716-545: 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)
6808-492: The median net worth (i.e., assets minus debt) for white households in the D.C. region was $ 284,000, while the median net worth for Hispanic–Latino households was $ 13,000, and for African American households as $ 3,500. Asian Americans had the highest median net worth in the Washington area ($ 220,000 for Chinese American households, $ 430,000 for Vietnamese American households, $ 496,000 for Korean American households, and $ 573,000 for Indian American households). Although
6900-521: The median net worth for white D.C.-area households was 81 times that of black D.C.-area households, the two groups had comparable rates of business ownership (about 9%). The Urban Institute report suggests that this "may be driven by the presence of a large federal government and a local district government whose membership and constituents have been largely Black, coupled with government policies designed to increase contracting opportunities for minority-owned businesses." The Washington metropolitan area has
6992-593: The metropolitan Washington area. Chartered in 1964, the Consortium of Universities of the Washington Metropolitan Area is a regional organization of 20 colleges and universities in the greater Washington, D.C. metropolitan area, the Smithsonian Institution , the U.S. Department of Defense (DoD), the Office of the Director of National Intelligence (ODNI), the U.S. Department of Health and Human Services (HHS),
7084-410: The metropolitan area are sometimes referred to as the National Capital Region, particularly by federal agencies such as the military, Department of Homeland Security , and some local government agencies. The National Capital Region portion of the Washington metropolitan area is also colloquially known by the abbreviation "DMV", which stands for the "District of Columbia, Maryland, Virginia." The region
7176-525: The nation. The median household income of the region is US$ 72,800. The two highest median household income counties in the nation – Loudoun and Fairfax County , Virginia – are components of the MSA (and No. 3 is Howard County , officially in Baltimore 's sphere but strongly connected with Washington's); measured in this way, Alexandria ranks 10th among municipalities in the region – 11th if Howard
7268-533: 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
7360-422: 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 ,
7452-535: The region to be close to the Pentagon in Arlington. Local defense contractors include Lockheed Martin , the largest, as well as General Dynamics , BAE Systems Inc. , Northrop Grumman , Computer Sciences Corporation (CSC) , Science Applications International Corporation (SAIC) , CACI , ManTech International , DynCorp , and Leidos . The Washington metropolitan area contains the headquarters of numerous companies in
7544-594: The region, a total eclipsed only by New York , Los Angeles , and the San Francisco Bay Area, as well as the highest master's or doctoral degree attainment among the 100 ranked metropolitan areas. A Dice.com report showed that the Washington–Baltimore area had the second-highest number of tech jobs listed: 8,289, after the New York metro area with 9,195 jobs. In 2020, the total gross domestic product for
7636-566: 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
7728-470: 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,
7820-448: 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
7912-458: 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
8004-482: The second largest concentration of journalists and media personnel in the United States after the New York metropolitan area . Washington's industry presence includes major publications with national audiences such as The Washington Post , U.S. News & World Report , and USA Today , as well as new media publishers such as Vox Media , RealClearPolitics , Axios , and Politico . A secondary portion of this market
8096-543: The second-largest metropolitan area in the Census Bureau's South Atlantic division, following Metro Atlanta . The U.S. Office of Management and Budget defines the area as the Washington–Arlington–Alexandria, DC–VA–MD–WV metropolitan statistical area, a metropolitan statistical area used for statistical purposes by the United States Census Bureau and other agencies. The region's three largest cities are
8188-470: The widespread availability of health care and facilities such as swimming pools, tennis courts, and parks, low rates of obesity and tobacco use relative to the national average, and the high median household income as contributors to the city's community health. In the 21st century, the Washington metropolitan area has overtaken the San Francisco Bay Area as the highest-income metropolitan area in
8280-533: 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
8372-407: Was elected in 1992, Democratic candidates have easily won the area by double-digits. The area has been a magnet for international immigration since the late 1960s. It is also a magnet for internal migration (persons moving from one region of the U.S. to another). Racial composition of the Washington metropolitan area. Source: Census Reporter The Washington metropolitan area has ranked as
8464-473: 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)
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