If the Over-the-Counter (OTC) Monograph User Fee Programme (OMUFA) is passed, it will include pre-submission meetings for proposed monograph changes.
Similar to The Prescription Drug User Fee Act (PDUFA) meetings, the US Food and Drug Administration (FDA) intends to provide requestors with various opportunities to meet with the FDA before OTC Monograph Requests (OMOR) submission and during OMOR review.
Whereas PDUFA designates such meetings as Type A, B, and C, OMUFA will analogously utilise Type X, Y, and Z to classify meetings. Type X will be for the discussion of stalled programmes, Type Y meetings will facilitate milestone discussions including pre-submission meetings, and Type Z meetings will be for all other OMOR topics.
Type Y pre-submission meetings will allow the requestor to present a summary of the data supporting the proposed OMOR and of the proposed format for the OMOR package, as well as to obtain FDA feedback on the adequacy of the proposed package. For an Innovation OMOR, the proposed Tier (One or Two) may also be discussed at the pre-submission meeting.
The pre-submission meeting should be held sufficiently in advance of the planned submission of the order request to allow for meaningful response to FDA feedback and should generally occur no less than three months prior to the planned submission of the order request.
Such meetings must be preceded by a meeting request and meeting background package. Once an OMOR is filed, the FDA will also schedule in-review meetings with requestors (anticipated to be between eight and nine months after receipt of the OMOR).
In-review meetings may be requested as face-to-face or as teleconferences.