- The U.S. Food and Drug Administration (FDA) is a federal agency within the U.S. Department of Health and Human Services responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, food supplies, cosmetics, and products that emit radiation. It also plays a key role in advancing public health by facilitating innovations that make medicines and products more effective, safe, and affordable.
- Established in its modern form by the Federal Food, Drug, and Cosmetic Act of 1938, the FDA has evolved to become one of the most influential regulatory bodies in the world. It sets and enforces standards for manufacturing practices, labeling, and clinical testing of products to ensure they meet stringent quality and safety requirements. The agency oversees the entire lifecycle of pharmaceutical and medical products—from research and development through manufacturing, marketing, and post-market surveillance.
- One of the FDA’s critical functions is the drug approval process, where it reviews data from clinical trials to determine whether a new drug is safe and effective for its intended use. For this, companies submit a New Drug Application (NDA) or a Biologics License Application (BLA). The FDA also regulates generic drugs through the Abbreviated New Drug Application (ANDA) process, ensuring they are bioequivalent to brand-name drugs.
- In addition to pharmaceuticals, the FDA regulates Good Manufacturing Practice (GMP) through inspections and audits. Facilities found to be non-compliant can face warning letters, product recalls, import bans, or legal action. The agency also monitors adverse events and product quality complaints through systems like MedWatch and requires companies to report serious issues related to their products.
- The FDA’s authority extends to food safety through regulations on food additives, labeling, and sanitation, especially under the Food Safety Modernization Act (FSMA). In the field of medical devices, the FDA classifies products based on risk and requires premarket approval for high-risk devices.
- Overall, the FDA serves as a guardian of public health in the United States and sets a regulatory benchmark followed by many other countries. Its actions not only influence healthcare and consumer safety domestically but also have significant global implications for product development and market access.
