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  5. FDA Related Laws, Regulations, and Guidances
  1. CDER Small Business & Industry Assistance (SBIA)

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.

  • CDER's MaPPs (Manual of Policies and  Procedures).  Series of formalized guidelines for CDER staff on internal policy.

  • Running Clinical Trials.  The FDA's regulations for the conduct of clinical trials, which have been in effect since the 1970s, address both good clinical practices (GCP) and human subject protection (HSP).  These FDA regulations and guidance documents are accessible from this site.  International GCP guidance documents on which FDA has collaborated and that have been adopted as official FDA guidance are also be found here.  Finally, this site includes links to other sites relevant to the conduct of clinical trials, both nationally and internationally

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