Food and Drug Administration (FDA) The Food and Drug Administration (FDA) is the U.S. federal agency responsible for protecting and promoting public health by regulating food, drugs, medical devices, biologics, cosmetics, tobacco products, veterinary products, and products that emit radiation. The agency evaluates safety, efficacy, and security across these categories, inspects production facilities, oversees clinical trial standards, and monitors product safety after market entry. What the FDA does
* Reviews and approves drugs, vaccines, medical devices, and other regulated products before they can be marketed in the United States.
* Inspects domestic and imported production facilities (e.g., drug and vaccine manufacturers, food processors, blood banks, compounding pharmacies).
* Monitors post-market safety, issues recalls, and enforces corrective actions when products pose risks.
* Collects and publishes health data, issues guidance, and conducts research.
* Supports food and medical product supply security and counterterrorism efforts related to public health.
History and organization
* Origins date to federal monitoring of agricultural products in the mid-19th century; the Pure Food and Drugs Act of 1906 established federal regulation of these products. The “Food and Drug Administration” name was adopted in 1930.
* The FDA is part of the Department of Health and Human Services and is led by a commissioner. It employs more than 18,000 people across all 50 states.
* The agency’s responsibilities in the U.S. are comparable to the European Medicines Agency (EMA) in the EU.
FDA approval process (typical path)
1. Discovery and development: Laboratory research and early design of a product or drug candidate.
2. Preclinical research: Lab and animal studies to assess dosing, toxicity, and safety to support human testing.
3. Clinical research: Human trials conducted in phases (Phase I–III) to evaluate safety and efficacy, with data collected for FDA review.
4. FDA review: Evaluation of submitted data to decide on approval, denial, or requests for more information.
5. Post-market safety monitoring: Ongoing surveillance of approved products, adverse event reporting, and potential post-approval studies or actions.
Inspections, recalls, and enforcement
* The FDA conducts routine, preapproval, and for-cause inspections of facilities and clinical trial sites.
* Imported regulated products are inspected at U.S. ports of entry.
* Recalls can result from contamination, undeclared allergens or ingredients, mislabeled products, or safety concerns; the FDA publishes recall announcements and works with manufacturers on corrective actions.
Impact on industry and investors
* FDA approvals are critical for companies in biotech, pharmaceuticals, medical devices, and related sectors; approval can drive significant commercial value and stock movement, while rejection can materially harm a company’s prospects.
* Clinical trial outcomes, regulatory decisions, and inspection findings are closely watched by investors as indicators of future revenue potential and regulatory risk.
How to verify FDA approval
* Search FDA databases such as the Orange Book (approved drug products) and Drugs@FDA.
* Contact FDA drug information (example resources listed by the agency) for additional verification and details.
* The FDA’s public webpages provide searchable records of approvals, clearances, and safety communications.
Key facts
* The FDA regulates a broad portfolio of products totaling trillions of dollars in commerce.
* Fiscal year 2023 FDA budget: approximately $6.7 billion.
* The agency continues to monitor approved products after market entry to protect public health.
Sources
* U.S. Food & Drug Administration — About FDA, What We Do, FDA History, Inspection Basics, Drug Development Process
* USA.gov — Food and Drug Administration information
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