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Posted On: 11/15/2025 10:15:57 AM
Post# of 158792
No.
If you like Chat, here's what it says about accelerated approval requiring a BLA or NDA:
And those are lengthy, complex documents that probably require a year of work. Ask AI.
If you like Chat, here's what it says about accelerated approval requiring a BLA or NDA:
Quote:
In the U.S., Accelerated Approval is not a separate application type — it is a pathway that can be applied to standard submissions.
It always requires either:
✅ An NDA (New Drug Application) for small-molecule drugs, or
✅ A BLA (Biologics License Application) for biologics.
And those are lengthy, complex documents that probably require a year of work. Ask AI.