Food and Drug Administration

FDA Facilities and Field Operations

• FDA headquarters located in Maryland with multiple buildings for various departments.
• White Oak Federal Research Center spans 130 acres and houses different offices.
• FDA has field offices, laboratories, and international presence in countries like China and India.
• FDA projects a significant increase in employees and campus expansion by 2035.
• The FDA oversees a vast scope of products totaling $2.7 trillion, with funding from the federal government and industry user fees.

Regulatory Programs and Oversight

• FDA regulates various products like prescription drugs, cosmetics, and food.
• The agency enforces standards, conducts facility inspections, and documents regulatory observations.
• Emergency Use Authorization aids in public health emergencies.
• FDA collaborates with third-party firms for regulatory oversight.
• The agency ensures fair balance in drug advertising and monitors post-market safety through reporting systems.

Drug Approval and Safety

• FDA’s Center for Drug Evaluation and Research oversees new, generic, and over-the-counter drugs.
• The agency expedites drug reviews and requires Risk Evaluation and Mitigation Strategies for some medications.
• Generic drugs must meet FDA approval standards through an Abbreviated New Drug Application process.
• FDA regulates drug advertising for approved indications and maintains oversight on off-label use.
• The agency works to ensure the safety and efficacy of pharmaceuticals through preclinical studies and clinical trials.

Biologics, Medical Devices, and Cosmetics Regulation

• FDA oversees biologics, medical devices, and cosmetics safety through various centers.
• Biologics require a Biologics License Application for approval.
• The Center for Devices and Radiological Health regulates medical and radiation-emitting devices.
• FDA requires premarket approval for color additives in cosmetics and intervenes when necessary for product safety.
• The agency collaborates with international bodies for drug and device safety regulations.

Food Safety and Tobacco Regulation

• FDA ensures food safety through inspections, safety standards enforcement, and collaborations with state agencies.
• The agency monitors food imports and implements regulations like the Food Safety Modernization Act.
• FDA regulates tobacco products under the Tobacco Control Act to reduce harm and addiction.
• The agency reviews new tobacco products for health risks and restricts youth access.
• FDA collaborates with public health organizations for tobacco cessation efforts and promotes safety in food, drugs, and tobacco products.

Food and Drug Administration Data Sources