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Life After Chevron: User Fee Cycle May Help US FDA In Era Of Uncertainty

 
• By Michael McCaughan

US federal agencies are entering a new era of uncertainty and increased litigation over their regulatory interpretations, but the FDA may benefit from the unique circumstances that have evolved through user fee legislation.

uncertainty
The FDA and Congress can use the user fee reauthorizations to deal with regulatory uncertainty. • Source: Shutterstock

The US Food and Drug Administration, like every federal agency, is entering a new era of uncertainty about the scope of its regulatory authority.

Key Takeaways

  • The five-year user fee reauthorization schedule allows Congress a vehicle for dealing with legal decisions impacting its authority, like the uncertainty following the Supreme Court’s...

The US Supreme Court’s 28 June decision overturning the so-called “Chevron Doctrine,” which guided judicial review of agency actions for decades, opens up new avenues to challenge FDA policies and...

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