Pink Sheet senior writers Derrick Gingery and Sarah Karlin-Smith, and Executive Editor Nielsen Hobbs discuss the impact of the midterm elections on the US Food and Drug Administration and health care policy, how sponsors are making product development decisions based on the Inflation Reduction Act’s price negotiation provisions, and new guidance addressing stakeholders’ expanded access questions.
Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy
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Pink Sheet reporters and editor discuss the impact of the midterm elections, the Inflation Reduction Act’s effects on drug development, and adjustments to FDA expanded access guidance.
Learn what's happening at the US FDA. On the go.
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The agency is clearly on the radar of former President Trump and his new coterie of tech moguls.
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With the 4 July UK general election less than two weeks away, the Pink Sheet looks at the manifestos published by the major political parties and finds pledges to drive innovation, boost clinical trial activity and speed up regulatory procedures.
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While more significant reforms are less likely under a second Biden term unless Democrats control both chambers of Congress, former President Trump could look to put his stamp on drug pricing reform by resurrecting one of his former policies involving international reference pricing and Medicare Part B drugs.
More from Legislation
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Congressional Budget Office responses to questions from US lawmakers on pharmacy benefit managers could add to the momentum for PBM reforms to go further than the current leading proposals.
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Letter to US FDA by a bipartisan group of House members cites clinical trials sponsored by Eli Lilly and Pfizer as examples of a widespread industry practice. But any legislation to curtail such practices is not expected to be part of the BIOSECURE Act.
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The agency is clearly on the radar of former President Trump and his new coterie of tech moguls.
