Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry
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- Title
- Formal Meetings Between the Food and Drug Administration and Sponsors or Applicants of Prescription Drug User Fee Act Products; Draft Guidance for Industry
- Posted
- Sep 22, 2023
- Comment period
- Sep 22, 2023 – Dec 22, 2023
- Topics
Overview
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Stance breakdown
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- May 2, 2026Comment from Matrix Corporation, New York, NyOtherAcademicRead comment →
- Apr 14, 2026Comment from RCSS (Regulatory Consulting & Scientific Solution)OtherIndividual
Dr. Nathalie Machluf is seeking clarification on specific details regarding the draft guidance, including meeting types for standard products, potential timeline differences for WRO meetings, and the effective date for implementation. The commenter does not express a clear stance of support or opposition to the proposed action.
Read comment → - Mar 9, 2026Comment from AnonymousSupportIndividual
The commenter asks why the specific procedures for meetings regarding animal model development for countermeasures (mandated by PAHPRA 2013) are not included in the draft guidance, suggesting they should be incorporated.
Read comment → - Dec 21, 2023Comment from Group of non-profit organizationsAnalysis pending📎 AttachmentRead comment →
- Dec 21, 2023Comment from EveryLife Foundation for Rare DiseasesAnalysis pending📎 AttachmentRead comment →
- Dec 21, 2023Comment from Gilead, Inc.Analysis pending📎 AttachmentRead comment →
- Dec 21, 2023Comment from Alan Boyd Consultants Inc.Analysis pending📎 AttachmentRead comment →
- Dec 20, 2023Comment from AbbVieAnalysis pending📎 AttachmentRead comment →
- Dec 18, 2023Comment from Biotechnology Innovation Organization (BIO)Analysis pending📎 AttachmentRead comment →
- Dec 14, 2023Comment from The Humane Society of the United StatesAnalysis pending📎 AttachmentRead comment →