In US OTC Monograph Program, ‘FDR’ Spells Appealing FDA's Rejections Of Change Requests
‘FDR’ Spells Process To Appeal FDA Rejections Of Requests For OTC Monograph Changes
Draft guidance adds “formal dispute resolution” to other terms becoming common in OTC drug sector since agency began overhaul of monograph drug program authorized in 2020. Others are OMOR, for OTC monograph order request, and OMUFA, for user fee program also authorized.
