The Food and Drug Administration (FDA) is a federal agency of the United States Department of Health and Human Services, one of the United States federal executive departments. Established on June 30, 1906, with the passage of the Pure Food and Drugs Act, the FDA is responsible for protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices; and by ensuring the safety of the nation's food supply, cosmetics, and products that emit radiation. Operating under the jurisdiction of the Federal Food, Drug, and Cosmetic Act (FD&C), the FDA also regulates the manufacturing, marketing, and distribution of tobacco products to protect public health.
The FDA's responsibilities extend vastly beyond initial approval of drugs and food products. It oversees not just clinical trials and medication effects, but also the monitoring of adverse_events that occur after widespread use of approved drugs. The FDA's post-marketing surveillance program uses a variety of tools, including the MedWatch program, which allows health professionals and consumers to report any adverse reactions. The agency uses this data to update product labels, restrict drug use, or even pull drugs off the market if necessary. This continual monitoring is critical in maintaining a high standard of public health safety and efficiency.
In addition to its regulatory functions, the FDA is also involved in advancing public health by facilitating innovations that make medicines and foods more effective, safer, and more affordable. The agency plays a key role in national_security by ensuring the security of the food supply and by fostering development of medical products to respond to public health threats. During health emergencies, such as the COVID-19 pandemic, the FDA has the authority to grant Emergency Use Authorizations (EUAs) to allow the use of unapproved medical products or unapproved uses of approved medical products when certain statutory criteria are met, demonstrating the agency’s crucial role in managing public health crises.
The FDA's reach is global, as it regulates products in an international market. It works with other nations' regulatory bodies to harmonize global standards for drug and food safety, which is vital in a world where the ingredients and products often cross multiple borders before reaching the consumer. The FDA's Office of International Programs works with global_partners to strengthen the quality, safety, and effectiveness of medical products around the world. The FDA also has a special focus on advanced manufacturing techniques, such as pharmaceutical_robotics and 3D printing of drugs, which are set to transform the methods of production and distribution in the coming years.
These diverse roles make the FDA a key player in health and safety regulation, continually adapting to the challenges of modern science and technology to maintain a high standard of public health across the USA and worldwide.