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The IRA And US FDA: How Will Agency View Any Drug Development Changes?

 
• By Michael McCaughan

US biopharma companies are warning of significant changes in drug development priorities as they prepare for the implementation of new Medicare pricing measures enacted in 2022. Those changes will have ripple effects on the FDA, which may spark some responses.

changing minds
How will the FDA deal with industry as it adapts to the IRA? • Source: Shutterstock

The drug pricing reforms enacted by the Inflation Reduction Act are casting a long shadow over the drug development sector as 2023 begins.

It isn’t that drug development will necessarily be crushed by the new law. Just that things are likely to change...

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