From a previous comment:
FDA Advisory Committees
Often, the NDA contains sufficient data for FDA to determine the safety and effectiveness of a drug.
Sometimes, though, questions arise that require additional consideration. In these cases, FDA may organize a meeting of one of its Advisory Committees to get independent, expert advice and to permit the public to make comments. These Advisory Committees include a Patient Representative that provides input from the patient perspective.
Ann: Rett Syndrome NDA accepted for Priority Review by FDA, page-6
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