Opportunity
Federal Register #FDA-2022-D-0080
FDA Issues Final Guidance on Formal Meetings for OTC Monograph Drugs
Buyer
Food and Drug Administration
Posted
July 14, 2026
Identifier
FDA-2022-D-0080
This opportunity is an announcement from the Food and Drug Administration (FDA) regarding final guidance for formal meetings related to over-the-counter (OTC) monograph drugs. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Purpose: - Issuance of final guidance titled "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs" - Guidance covers procedures and recommendations for formal meetings between FDA and sponsors/requestors of OTC monograph drugs - Key Details: - Outlines how to request meetings, available meeting types (in-person, virtual, teleconference, written response) - Applies to meetings seeking FDA advice on studies, submissions, and development of OTC monograph drugs, including those under investigational new drug applications (INDs) - No procurement of products or services is involved - OEMs and Vendors: - No OEMs or vendors are mentioned, as this is a policy guidance document - Products/Services Requested: - No products, part numbers, or quantities are requested - Unique/Notable Requirements: - Focuses on regulatory procedures and industry-FDA interactions, not on acquisition of goods or services
Description
The Food and Drug Administration (FDA) announces the availability of a final guidance for industry titled "Formal Meetings Between FDA and Sponsors or Requestors of Over-the-Counter Monograph Drugs." This guidance provides recommendations on formal meetings between FDA and sponsors or requestors of OTC monograph drugs or their representatives, discussing procedures and principles for these meetings. It finalizes the draft guidance issued on February 7, 2022, and is issued under the Federal Food, Drug, and Cosmetic Act (FD&C Act). The guidance applies to meetings to obtain advice on studies, submissions, and development of OTC monograph drugs, including clinical investigations under investigational new drug applications (INDs).