The FDA’s Advisory Committee (AdCom) are expert panelists that vote up or down on whether to recommend approval of a drug. Adcom meetings are catalyst events that move biotech stocks either up or down.
Briefing documents are disseminated to the public two days ahead of the AdCom meeting itself. AdComs are not required, but when products are truly new in their mechanisms of action or composition of matter, or when they are intended for chronic, lifetime use, AdComs are convened. The FDA can overrule the panel vote, but most often the agency follows the AdCom recommendation.<< Back to Glossary Index