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USFDA - Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs

US Food and Drug Administration (FDA) issued draft guidance discussing formal meetings between sponsors of over-the-counter (OTC) monograph drugs and the agency. This draft guidance provides recommendations to industry on formal meetings between FDA and sponsors or requestors of over-the-counter (OTC) monograph drugs.

This guidance provides recommendations to the industry on formal meetings between the Food and Drug Administration (FDA) and sponsors or requestors of nonprescription drugs without approved new drug applications.


This guidance specifies the procedures and principles for formal meetings between FDA and sponsors or requestors for an OTC monograph drug. In doing so, it describes procedures under which meeting requesters can meet with appropriate FDA officials to obtain advice on the studies and other information necessary to support submissions to obtain advice on other matters relevant to the regulation of nonprescription drugs, and to obtain advice on the development of new OTC monograph drugs.


This guidance discusses the principles of good meeting management practices and describes standardized procedures for requesting, preparing, scheduling, conducting, and documenting such formal meetings.


There are three types of formal meetings that may occur between meeting requesters and FDA staff to obtain advice on the studies and other information necessary to support OTC monograph order submissions, to obtain advice on other matters relevant to OTC monograph drug regulation, or to obtain advice on OTC monograph drug development:

  1. Type X

  2. Type Y

  3. Type Z

To know more on the types of meetings click the LINK

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