What are FDA Advisory committee meeting documents

Last updated on March 09, 2020

The FDA Advisory committees provide independent advice and recommendations to the FDA on scientific and technical matters related to the development and evaluation of products regulated by the Agency.

The FDA has 31 advisory committees, each with a dedicated theme. Some examples are the Anti-Infective Drugs Advisory Committee, the Oncologic Drugs Advisory Committee and the Peripheral and Central Nervous System Drugs Advisory Committee.

Advisory committees include a chair, several members, plus a consumer, industry, and sometimes a patient representative. Additional experts with special knowledge may be added for individual committee meetings as needed. Although the committees provide advice to the agency, FDA makes the final decisions.

The meeting documents include, briefing, background and transcripts, and contain critical insights for drug developers. Although documents are public domain information, they are really hard to access, and not searchable in full text. Thereby most of the rich content is not utilized.

PharmaPendium provides access to FDA advisory committee meeting documents that can be searched in full text and be filtered based on committee subject. FDA advisory committee meeting content can be accessed in PharmaPendium through Quick search or Advanced search.

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