What is the appropriate process to request amendment or repeal of conditions covered by exiting proposed or final OTC monographs?
An NDA can be used to request approval of an OTC drug that deviates in any respect from a monograph that has become final (see 21CFR 330.11). However, a citizen petition (see 21 CFR 10.30) is another means to request an amendment or repeal of conditions covered by an existing proposed or final OTC drug monograph. In order for FDA to act on the petition, accompanying data must demonstrate general safety and effectiveness (or lack thereof). An advantage of submitting a citizen petition is that a Prescription Drug User Fee Act (PDUFA) fee is not required as with a NDA. But the NDA process does provide confidentiality during the review, an established review timeframe (as provided under PDUFA), and a period of potential marketing exclusivity upon approval, if certain conditions are met.
Related Questions
- Within both organizations who was responsible for the review of the final proposed affiliation documents and what was their process?
- What is the appropriate process to request amendment or repeal of conditions covered by exiting proposed or final OTC monographs?
- How long does it take from the time that I request a due process hearing until the Hearing Officer makes a final decision?
