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.


Sponsors can request that meetings be held face-to-face, via a teleconference, or through written response only (WRO).

Meetings Types and Timelines

Meeting typesDefinitionFDA’s Response Time (calendar days from receipt of meeting request/WRO requestMeeting
or WRO times
Type Xmeetings are for “otherwise stalled” OTC monographs, or those products subject to a refuse-to-file letter14 days30 calendar days from receipt of meeting request
Type Ymeetings are for “milestone” discussions for an OTC monograph under development,14 days70 calendar days from receipt of meeting request
Type ZType 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.

GRP Services for Regulatory Affairs and Audits in the USA:

Contact us, to learn more how GRP can help you: Regulatory Affairs (Anvisa, FDA,EMA among other Countries), register your medical devices, Drug Registration. Contact us before you receive your rescission notice from the FDA.

  •  Regulatory affairs consulting for medical devices and IVDs.
  •  FDA 510(k) premarket notification for medical device and IVDs.
  •  FDA PMA premarket application for medical device and IVDs.
  •  FDA IDE for investigational medical devices and IVDs.
  •  FDA QMS implementation and inspection.
For additional information contact GRP at info@globalregulatorypartners.com

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

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices, pharmaceutical, cosmetic and Food Supplement companies globally.

GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, and Mexico. GRP helps many life science companies register their products in different countries in compliance with local regulations. 

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