The Food and Drug Law Institute (FDLI) is an organization committed to providing quality education and a neutral forum for the generation of ideas and discussion of law and public policy for its legal, policy, and regulatory communities.
FDLI is an organization of more than 570 members - manufacturers and suppliers of medicines such as pharmaceuticals, biologics and biotechnologies; medical devices, food, and cosmetics subject to FDA regulation; law and consulting firms; associations; and individuals.
Each year, FDLI sponsors more than 20 conferences and workshops, which focus on a variety of issues affecting FDA-regulated industries. The US Food and Drug Administration (FDA) is the government agency responsible for regulating food, drugs, biology, cosmetics, medical devices and blood products in the United States. The mission of the US Food and Drug Administration is to:
- Promote the public health by promptly and efficiently reviewing clinical research and taking appropriate action on the marketing of regulated products in a timely manner;
- Protect the public health by ensuring that foods are safe, wholesome, sanitary, and properly labeled; human and veterinary drugs are safe and effective;
- Make sure there is reasonable assurance of the safety and effectiveness of devices intended for human use;
- Ensure cosmetics are safe and properly labeled, and public health and safety are protected from electronic product radiation.
FDA participates through appropriate processes with representatives of other countries to reduce the burden of regulation, harmonize regulatory requirements, and achieve appropriate reciprocal arrangements; and carry out the consultation with experts in science, medicine, and public health, and in cooperation with consumers, users, manufacturers, importers, packers, distributors and retailers of regulated products. Located in Washington, D.C, the FDLI is governed by a Board of Directors that meets four times per year. Other bodies include an Advisory Board and the following committees: Academic, Drug/Biologics, Food/Dietary Supplement, Medical Device, Finance, Audit, Legal, Membership and Nominations.
The FDLI presents conferences and publications for comprehensive discussion of major policy, legislative, regulatory, and enforcement actions and judicial decisions; and provides education and training in the practice of food and drug law and regulation. FDLI's mission relates to the regulatory programs of the FDA as well as the U.S. Department of Agriculture, Federal Trade Commission, Department of Justice, Environmental Protection Agency, and other federal and state government agencies as they pertain to human and veterinary drugs, biologics and biotechnology products, medical devices, food, and cosmetics.
FDLI produces the award-winning peer-reviewed Food and Drug Law Journal, the bimonthly magazine update, and a selection of publications that provide a comprehensive set of resources related to food and drug law and regulation.