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Saturday, April 13, 2024 3:51:29 PM
Most of the PI funding to the FDA comes in the form of NDA application fees. The FDA gets that money from the company applying for an NDA up front. Since the FDA is the only game in town the approval rate has little to do with the amount of money the FDA gets.
If a company wants access to the US market they have to pay the application fee to the FDA. The implication that there is a quid pro quo involved doesn't stand up to scrutiny. The fee schedule is published. All PI companies pay the same fees.
You can argue about the approval of the Aduhelm drug against the advisory committee advice and that would be a legit argument. That also lead to investigations etc.
Nunc est Bibendum
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