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CDER Guidance Agenda

January 2025

Download the Guidance Agenda

Docket Number: FDA-2024-N-5313
Issued by: Center for Drug Evaluation and Research

This is the list of guidances that CDER is considering for development during calendar year 2025. The list includes first issuance of a level 1 draft guidance and level 1 guidances previously issued and being revised. We currently intend to develop guidance documents on these topics, but we are not bound by this list of guidances, nor required to issue every guidance document on the list.  We are not precluded from developing guidance documents on topics not on this list. 

Submit Comments

Submit Comments Online

Submit comments online on the guidance agenda to docket FDA-2024-N-5313. If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2024-N-5313.

 

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