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Pink Sheet Podcast: Election Fallout, IRA Impacting Product Development, Updated US FDA Expanded Access Policy

 
• By Derrick Gingery, Sarah Karlin-Smith, and Nielsen Hobbs

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.

Pink Sheet podcast
Will the new Congress attempt to change the drug price negotiation provisions of the Inflation Reduction Act? • Source: Pink Sheet illustration

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.

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Korean Pharma Industry Proposes Policies As Election Nears

 
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Bracing For RFK At HHS: Vaccine Safety Commission Likely First Step

 
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More from Legislation

BIOSECURE Act Returning, Privacy, Gain-of-Function Bills Coming, Senate Sponsor Says

 
• By Laura Helbling

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Korean Pharma Industry Proposes Policies As Election Nears

 
• By Jung Won Shin

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

Non-User Fee Dollars Increased In US FDA’s Updated FY 2026 Budget Request

 
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The budget authority total, which is significantly higher than the amount floated in an April OMB draft document, suggests there may have been successful lobbying to increase FDA funding.