Summary of the FDA's process for rulemaking.
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Food and Drug Administration Safety and Innovation Act
FDASIA gives FDA the authority to collect user fees and fund review of innovator drugs, medical devices, generic drugs and biosimilar products.
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Guidelines for making a Freedom of Information Act request for public information.
Federal Food, Drug, and Cosmetic Act
Online access to the FDA's principal authorizing legislation.
Rabies: Developing Monoclonal Antibody Cocktails for the Passive Immunization Component of Post-Exposure Prophylaxis Guidance for Industry
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