Comments Regarding OTC Monograph Order Request (OMORs): Format and Content

Industry appreciates this guidance to enable the assembly of suitable and successful OMORs. We reiterate that FDA must adopt standards and expectations consistent with the intent of OMUFA, rather than the NDA paradigm, with which it is very familiar. The OMUFA innovation pathway will be successful when industry and FDA align on requirements for GRASE status of ingredients and data requirements for an OMOR submission.