Federal Register #FDA-2017-D-6530

FDA Issues Final Guidance on Formal Meetings for PDUFA Products

This notice announces the release of a final guidance document by the Food and Drug Administration (FDA) for industry stakeholders involved in the development and review of prescription drug and biological products. - Government Buyer: - Department of Health and Human Services (HHS) - Food and Drug Administration (FDA) - Center for Drug Evaluation and Research (CDER) - Center for Biologics Evaluation and Research (CBER) - OEMs and Vendors: - No OEMs or commercial vendors are mentioned; the only product is the FDA-issued guidance document - Products/Services Requested: - Final guidance document: "Formal Meetings Between the FDA and Sponsors or Applicants of Prescription Drug User Fee Act (PDUFA) Products" - No quantities or part numbers specified - Unique or Notable Requirements: - The guidance standardizes procedures, meeting types, formats, and timelines for formal meetings between the FDA and sponsors/applicants - Aims to improve communication and regulatory clarity for drug and biologics development - This is an informational release, not a procurement or solicitation

Description

The Food and Drug Administration (FDA) has announced the availability of a final guidance for industry titled "Formal Meetings Between the FDA and Sponsors or Applicants of PDUFA Products." This guidance provides recommendations on formal meetings between FDA and sponsors or applicants related to the development and review of new drug or biological products regulated by CDER and CBER. It outlines good meeting management practices, standardized procedures for requesting and conducting meetings, and provides examples to guide stakeholders in selecting appropriate meeting types. The guidance finalizes a draft issued in September 2023 and aims to facilitate effective communication and clarity in the meeting process.

View original listing