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

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

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter, Managing Editor Bridget Silverman and Editor-in-Chief Nielsen Hobbs consider strategies that incoming President Donald Trump and his team could use to make their promised US Food and Drug Administration reforms (:24), outgoing Center for Drug Evaluation and Research Director Patriza Cavazzoni’s comments about agency staffing and publishing reviews of applications that received complete response letters (12:35), and new application approval patterns in CDER as well as the Center for Biologics Evaluation and Research (21:53).

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