The U.S. Food and Drug Administration (FDA or USFDA) is an agency of the United States Department of Health and Human Services and is responsible for regulating and supervising the safety of foods, dietary supplements, drugs, vaccines, biological medical products, blood products, medical devices, radiation-emitting devices, veterinary products, and cosmetics. The FDA also enforces section 361 of the Public Health Service Act and the associated regulations, including sanitation requirements on interstate travel as well as specific rules for control of disease on products ranging from pet turtles to semen donations for assisted reproductive medicine techniques.

This topic describes: USFDA Guidelines for Clinical Research, Synthesis and Purification, Pre-Clinical Research, Animal Testing, Short-Term Testing, Long-Term Testing, Animal Pharmacology and Toxicology Studies, Manufacturing Information, Clinical Protocols and Investigator Information, Sponsor/FDA Meetings (Pre-IND), New Drug Application (NDA).

Regulatory Environment in US (FDA)

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