Pink Sheet Podcast: US FDA And Trump’s Reforms, CDER Director Parting Comments, 2024 Approval Trends

 
• By Derrick Gingery, Sue Sutter, Bridget Silverman, and Nielsen Hobbs

Pink Sheet editors consider ex-FDA officials’ advice for the Trump Administration on implementing FDA reforms, comments CDER Director Patrizia Cavazzoni made before her departure from the agency about wanting to release review documents for applications that received complete response letters, and diverging trends between CDER and CBER novel application approvals.

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Could the FDA determine a legal way to reveal the contents of complete response letters? • Source: Citeline/Shutterstock

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