On February 1st, 2022, the US Food and Drug Administration (FDA) issued a draft of guidance on formal meetings between sponsors of over-the counter (OTC) monograph drugs and the agency.
The guidance clarifies how sponsors can obtain advice on studies to support their submissions. It also addresses meeting types, meeting formats, content of meeting requests meetings, the agency’s timelines for responding to meeting requests, the meeting package, and rescheduling or cancelling process of such meetings.
WHAT IS THE FORMAT OF THE MEETINGS?
Sponsors can request that meetings be held face-to-face, via a teleconference, or through written response only (WRO).
Meetings Types and Timelines
|Meeting types||Definition||FDA’s Response Time (calendar days from receipt of meeting request/WRO request||Meeting |
or WRO times
|Type X||meetings are for “otherwise stalled” OTC monographs, or those products subject to a refuse-to-file letter||14 days||30 calendar days from receipt of meeting request|
|Type Y||meetings are for “milestone” discussions for an OTC monograph under development,||14 days||70 calendar days from receipt of meeting request|
|Type Z||Type Z meetings those that do not fall under either Type X or Type Y meetings.||21 days.||75 calendar days from receipt of meeting request|
Content of Meeting Request
- Brief statement of goals the sponsor hopes to achieve through the meetings,
- a Proposed agenda,
- a statement of whether the sponsor intends to discuss information exempt from disclosure under Section 505G(d) of the Food, Drug and Cosmetic Act
- 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.
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OTC monograph facility
Following a dispute with the Department of Health and Human Services (HSS) that resulted in its initial notice being withdrawn, the US Food and Drug Administration (FDA) on Thursday reissued its notice announcing fee rates for its newly created over-the-counter (OTC) monograph drug user fee program (OMUFA) for FY2021
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