In the May 11, 2016, Federal Register, FDA announced a public meeting to gather stakeholder input on the potential development of a user-fee program for nonprescription (i.e., OTC) monograph drugs. If implemented, the program would: (i) provide funding to supplement congressional non-user-fee appropriations and (ii) support timely and efficient FDA review of the efficacy and safety of ingredients included in or proposed for inclusion in a monograph. FDA seeks public comment on the potential user-fee program and suggestions for features to be included in the program. FDA has also published related Frequently Asked Questions on its website. The public meeting will be held June 10, 2016.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.