U.S. Food and Drug Administration
Protecting and Promoting Your Health
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Center for Drug Evaluation and Research
Engaging with the FDA During New Drug Development
Formal Meetings with FDA
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CDER 21st Century Review (Cont.)

Meetings facilitate complete and fileable applications. All applicants are strongly encouraged to request a meeting with the appropriate FDA review division during the pre-submission activity phase. Meeting types may include:

Image of the NDA/BLA Review Process Timeline. Click to Enlarge Overview of the NDA/BLA Review Process and Major Steps for Completing the Review. Click to Enlarge.
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