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FDA Related Laws, Regulations, and Guidances

The mission of  FDA is to enforce laws enacted by the U.S. Congress and regulations established by the Agency to protect the consumer's health, safety, and pocketbook.  The Federal Food, Drug, and Cosmetic Act is the basic food and drug law of the U.S. With numerous amendments it is the most extensive law of its kind in the world.  The law is intended to assure the consumer that foods are pure and wholesome, safe to eat, and produced under sanitary conditions; that drugs and devices are safe and effective for their intended uses; that cosmetics are safe and made from appropriate ingredients; and that all labeling and packaging is truthful, informative, and not deceptive.

  • Compliance Resources from the Office of Regulatory Affairs. (ORA) ORA is the lead office for all field activities of the FDA. This page provides links to documents, policies, and statements relating to regulatory compliance.  

  • Drug Registration and Listing System.  A firm must register and list their commercially marketed drug product with FDA.  Information is provided on these requirements.

  • Inspection References.  Information provided to FDA investigators and facilities inspectors to assist them in their daily activities.

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FDA/Center for Drug Evaluation and Research
Last Updated: September 2, 2005
Originator: OTCOM/DLIS