The FDA PDUFA VII Goals Letter (FY 2023-2027): A Review of Our Top 10 Commitments
FDA Law Blog
SEPTEMBER 20, 2021
The sponsor then gets the review ball rolling by submitting all of the efficacy supplement minus the final clinical study reports and clinical summaries. based upon the anticipated clinical benefit of earlier patient access to the product.”. Notable Dates and Timelines – Applications open, Q4 of FY 2023.
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