FDA Advisory Committee update
FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously on October 25 that long-term efficacy studies for antidepressants should not be required prior to approval.
FDA's Psychopharmacologic Drugs Advisory Committee voted unanimously on October 25 that long-term efficacy studies for antidepressants should not be required prior to approval.
Committee members stated that long-term efficacy data are needed for antidepressants but not necessary prior to approval. The studies should be conducted as soon as possible, according to the panel, possibly by at least initiating the trials or having FDA approve trial design prior to approval of the drug. Other committee members commented that long-term safety studies, not efficacy studies, should be of primary concern to FDA.
Source FDC Reports. Antidepressant long-term studies prior to approval should not be required, cmte. says. Available at: http:// http://www.fdaadvisorycommittee.com/. Accessed November 4, 2005.
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