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I just want to clarify the approval process for a new drug once the NDA (New Drug Application) has been submitted by the company.

PDUFA--Prescription Drug User Fee Act--was originally passed back in the early 1990s to speed up the approval review process. It's a fee paid by pharmaceutical companies that permits the hiring of more reviewers so that a huge backlog doesn't build up. Paying the fee guarantees that the review process will be completed and a decision will be reached--which may be 'yes' or may be 'no'--by 10 months. So the PDUFA date is when the decision to approve or reject will be announced.

See https://www.fool.com/knowledge-center/what-is-a-pdufa-date.a...

And the application/data are always reviewed by a committee. Always. The one aspect that is sometimes modified is when the nuclear committee at the FDA is augmented with outside experts because of their unique and needed expertise for a new drug under review.

I hope this helps.

=sheila
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