FDA drafts guidance on formal meetings with OTC sponsors

Regulatory NewsRegulatory News | 02 February 2022 | By

The US Food and Drug Administration (FDA) issued draft guidance on Tuesday discussing formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency. The guidance fulfills a mandate of the OTC monograph drug user fee program (OMUFA), which directed FDA to establish procedures and policies for these meetings.
 
The 20-page guidance specifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, how sponsors can request meetings, the agency’s timelines for responding to meeting requests, the meeting package, and the rescheduling and cancelling of meetings.
 
OMUFA was created in March 2020 under the Coronavirus Aid, Relief, and Economic Security Act (CARES Act) to modernize the agency’s regulation of OTC monograph products.
 
FDA published the OMUFA fees it would collect in FY2021 last March; fee rates for FY2022 are not yet available. (RELATED: FDA increases OTC monograph facility fees in reissued notice, Regulatory Focus 26 March 2021)
 
Three types of meetings
 
The draft says that meetings fall in three categories: Type X, Type Y and Type Z. Type X meetings are for “otherwise stalled” OTC monographs, or those products subject to a refuse-to-file letter. Type Y meetings are for “milestone” discussions for an OTC monograph under development; Type Z meetings those that do not fall under either Type X or Type Y meetings.
 
Sponsors can request that meetings be held face-to-face, via a teleconference, or through written response only (WRO).
 
Meeting requests should include the following information: the OTC monograph order request (OMOR); the proposed therapeutic category; the chemical name; the established name; the proposed indication; the meeting type requested; suggested dates and times; and a list of questions grouped by FDA discipline.
 
Requests should also include a brief statement of goals the sponsor hopes to achieve through the meetings, a proposed agenda, and a statement of whether the sponsor intends to discuss information exempt from disclosure under Section 505G(d) of the Food, Drug and Cosmetic Act.
 
For meeting Types X and Y, FDA will respond within 14 days, and for Type Z meetings, 21 days.
 
The guidance also provides a timetable for meeting scheduling or WRO times: for Type X meeting types, FDA will notify sponsors within 30 calendar days upon receiving meeting requests; 70 days for Type Y meetings and 75 calendar days for Type Z meetings. FDA will also notify the requestors under the same timelines if a meeting request is denied.
 
Draft guidance

 

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Tags: OMUFA

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