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Regulatory Intel
February 19 2024
FDA Publishes CDER & CBER 2024 Guidance Agendas

CDER and CBER have issued their guidance agendas for 2024.  See links below. 

There is one much-anticipated guidance required by FDORA (Food and Drug Omnibus Reform Act of 2022) that you won’t see on either of these lists: Updated guidance on clinical trial diversity plans. That’s because the Office of the Commissioner is handling that one. Stay tuned. 

CDER: CDER Guidance Agenda New, Revised Draft and Immediately in Effect Guidances Planned for Publication in Calendar Year 2024 

CBER: Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2024