**FDA Headquarters and Facilities:**
– FDA headquarters are located in Montgomery County and Prince Georges County, Maryland.
– The agency’s main headquarters are at the White Oak Federal Research Center in Silver Spring, Maryland.
– The FDA campus houses various offices and laboratory buildings.
– The FDA has facilities on 130 acres of the White Oak Federal Research Center.
– The campus houses over 10,000 employees in various offices and laboratories.
– New construction is expected to add 1.6 million square feet of space to the FDA campus.
**FDA Regulatory Scope and Funding:**
– The FDA oversees products totaling $2.7 trillion in value.
– 54% of the FDA’s budget comes from the federal government.
– Industry user fees cover 46% of the FDA’s budget.
– Forbes reports that pharmaceutical firms fund 75% of the FDA’s drug review budget.
**FDA Regulatory Programs and Approvals:**
– FDA regulates prescription drugs comprehensively.
– FDA uses Emergency Use Authorization (EUA) to expedite the authorization of products for public health crises.
– FDA enforces standards with facility inspections.
– FDA ensures compliance with the Dietary Supplement Health and Education Act (DSHEA) for dietary supplements.
– FDA has different requirements for new, generic, and over-the-counter drugs.
**FDA Post-Market Surveillance and Safety Measures:**
– Sponsors report adverse drug experiences to FDA after NDA approval.
– FDA may require additional clinical trials or Risk Evaluation and Mitigation Strategies (REMS) for drugs with significant risks.
– REMS programs are implemented for drugs with significant risks.
– Generic drugs are typically less expensive than name-brand drugs.
**FDA Regulation of Specific Products:**
– FDA oversees quality of substances sold as food in the US.
– FDA regulates cosmetics labeling and safety.
– FDA regulates tobacco products under the 2009 Family Smoking Prevention and Tobacco Control Act.
– FDA regulates animal drugs and food through the Center for Veterinary Medicine.
– FDA distinguishes between FDA-cleared and FDA-approved medical devices.
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.
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| Agency overview | |
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| Formed | June 30, 1906 |
| Preceding agencies |
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| Jurisdiction | Federal government of the United States |
| Headquarters | White Oak Campus 10903 New Hampshire Avenue Silver Spring, Maryland 20993 39°2′7″N 76°58′59″W / 39.03528°N 76.98306°W |
| Employees | 18,000 (2022) |
| Annual budget | US$6.5 billion (2022) |
| Agency executives |
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| Parent agency | Department of Health and Human Services |
| Child agencies |
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| Website | fda |
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.[update]
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.
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