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U.S. Department of Health and Human Services

Drugs

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Laws, Regulations, Policies and Procedures for Drug Applications

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.

Code of Federal Regulations for Investigational New Drugs (INDs), New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs) and Biologics License Applications (BLAs)

The following Code of Federal Regulations(CFR) sections provide regulations for INDs, NDAs and BLAs.  All parts of section 21 of the Code of Federal Regulations are also available.

    Part 600-Biological Products: General

    Part 601-Licensing

    Part 610-General Biological Products Standards  

   
Manual of Policies and Procedures (MaPPs

MaPPs provide official instructions for internal practices and procedures followed by Center for Drug Evaluation and Research (CDER) staff to help standardize the IND and NDA review process. All CDER MaPPs are available from the MaPP Index web page.