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Food and Drug Administration

<h2>FDA Headquarters and Field Locations</h2> – FDA headquarters are located in Montgomery County and Prince Georges County, Maryland. – The White Oak Federal Research Center […]

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<h2>FDA Headquarters and Field Locations</h2>
– FDA headquarters are located in Montgomery County and Prince Georges County, Maryland.
– The White Oak Federal Research Center in Silver Spring, Maryland, houses FDA facilities and employees.
– FDA campus at White Oak includes various offices and laboratory buildings.
– The FDA Reauthorization Act of 2017 projects a significant increase in FDA employees by 2035.
– The National Capital Planning Commission approved a master plan for FDA campus expansion in December 2018.
– Field locations include the Arkansas Laboratory in Jefferson, Arkansas, and various U.S. and international offices.
– The Office of Regulatory Affairs conducts fieldwork and is divided into five regions and 20 districts.
– The Office of Criminal Investigations employs Special Agents to investigate criminal cases.

<h2>FDA Scope, Funding, and Regulatory Programs</h2>
– FDA oversees $2.7 trillion in food, medical, and tobacco products as of 2021.
– 54% of the FDA’s budget comes from the federal government, while industry user fees cover 46%.
– Pharmaceutical firms contribute significantly to the FDA’s drug review budget.
– Regulatory programs include Emergency Use Authorization (EUA) for medical countermeasures during emergencies.
– EUAs are issued based on specific criteria, including the absence of adequate alternatives.

<h2>Regulations and Oversight</h2>
– FDA regulates prescription drugs comprehensively, focusing on labeling and safety for cosmetics.
– The agency enforces standards through facility inspections and released guidelines for food and drug protection in 2018.
– FDA distinguishes between FDA-Approved and FDA-Accepted in food processing.
– Regulatory shaming tactics are employed for compliance.
– The FDA regulates advertising and promotion of drugs, ensuring adherence to approved indications.

<h2>Drug Approval and Safety</h2>
– FDA has different requirements for new, generic, and over-the-counter drugs.
– New drugs undergo extensive scrutiny before approval, with expedited processes available.
– Post-market safety surveillance includes reporting adverse events and implementing risk management plans.
– Generic drugs must demonstrate equivalence to brand-name drugs and undergo an Abbreviated New Drug Application (ANDA) process.
– FDA oversees OTC drugs like aspirin and maintains a list of approved ingredients for over 100,000 products.

<h2>FDA Oversight on Various Products</h2>
– FDA oversees food quality, dietary supplements, medical countermeasures, and tobacco products.
– The agency regulates medical and radiation-emitting devices, cosmetics, and veterinary products.
– FDA ensures compliance with regulations, conducts inspections, and enforces laws to protect public health.
– Specific regulatory bodies like the Center for Devices and Radiological Health (CDRH) and the Center for Veterinary Medicine (CVM) oversee different product categories.

Food and Drug Administration (Wikipedia)

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.

Food and Drug Administration
Agency overview
FormedJune 30, 1906; 117 years ago (1906-06-30)
Preceding agencies
  • Food, Drug, and Insecticide Administration (July 1927 – July 1930)
  • Bureau of Chemistry, USDA (July 1901 – July 1927)
  • Division of Chemistry, USDA (established 1862)
JurisdictionFederal government of the United States
HeadquartersWhite Oak Campus
10903 New Hampshire Avenue
Silver Spring, Maryland 20993
39°2′7″N 76°58′59″W / 39.03528°N 76.98306°W / 39.03528; -76.98306
Employees18,000 (2022)
Annual budgetUS$6.5 billion (2022)
Agency executives
Parent agencyDepartment of Health and Human Services
Child agencies Edit this at Wikidata

The FDA's primary focus 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 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 17 February 2022.

The FDA's headquarters is located in unincorporated White Oak, 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 Building 31 houses the Office of the Commissioner and the Office of Regulatory Department of Health and Human Services. The agency consists of fourteen Centers and Offices.

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