The FDA makes use of federal advisory committees in an effort to receive independent advice from outside experts regarding regulatory decision making. Under US law (Federal Advisory Committee Act), meeting materials made available to committee members must be made available to the public at or before the time of the meeting. Meeting materials generally consist of two types: sponsor submitted materials and FDA submitted materials. These materials may contain limited data from clinical trials, but can include data not available elsewhere as well as FDA analyses of data (e.g. pooled analyses or sensitivity analyses). Unlike the Drugs@FDA database, Advisory Committee meeting materials may discuss applications that ultimately are not approved by the FDA, and as such serve as a source of unpublished data. Materials are, however, released to the public subject to the Freedom of Information Act (FOIA), which the FDA interprets as exempting certain types of information from disclosure, and therefore the publicly accessible versions may contain redactions. FDA posts Advisory Committee materials on its website, and generally also posts meeting minutes and a meeting transcript.
Advisory Committee meeting materials homepage: http://www.fda.gov/AdvisoryCommittees/CommitteesMeetingMaterials/default.htm
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