FDA OTC internal analgesic claims proposal in development as amendment to TFM.
This article was originally published in The Tan Sheet
Executive Summary
FDA INTERNAL ANALGESIC CLAIMS PROPOSAL IN DEVELOPMENT at the agency as an amendment to the Nov. 16, 1988 OTC tentative final monograph on internal analgesics. The proposal is expected to require that products only will be able to claim relief from menstrual cramps, headache and fever based on clinical data in pain models specifically addressing those conditions.