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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

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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This and other podcasts are available on the Pink Sheet podcast page, as well as the Citeline channel on Apple Podcasts, SoundCloud, TuneIn and Spotify Podcasts, and via smart speakers if one of these platforms has been set up as your default podcast provider.

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Pink Sheet Podcast: A New Director For US FDA’s Biologics Center, Guidance Production Slowdowns

 
• By Derrick Gingery, Sue Sutter, and Nielsen Hobbs

Pink Sheet editors discuss the appointment of Vinay Prasad as the new director of the Center for Biologics Evaluation and Research and revelations that FDA layoffs now are hindering development of guidance documents.

Pink Sheet Podcast: Vaccine Review Political Interference, Missed Deadlines A Harbinger Of US FDA Problems?

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

Pink Sheet reporter and editors discuss FDA Commissioner Martin Makary’s decision to have one of his assistants lead negotiations for Novavax’s delayed COVID-19 vaccine review, as well as some recent missed review deadlines, which may be the result of recent FDA cuts.

How Tumult At US FDA Could Impact Merger and Acquisition Strategy

 
• By Joseph Haas and Nielsen Hobbs

With review and development uncertainly increasing, "it’s going to take longer for certain targets … to progress to a place where they’ve been derisked enough that big pharma is ready to write a big check," said Andrew Goodman of Paul Hastings.

Pink Sheet Podcast: More US FDA Departures, Makary On Combined AE Database, ‘Conditional’ Approval

 
• By Derrick Gingery, Sarah Karlin-Smith, and Sue Sutter

Pink Sheet reporter and editors discuss the most recent senior staff departures at the FDA and their impact on the agency, as well as Commissioner Martin Makary’s plans for a new approval pathway and a combined adverse event database as outlined in an interview with a podcast host.

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US FDA’s Accelerated Approval Council: Bigger Role, More Transparency Coming?

 
• By Sue Sutter

The inspector general said the council should be more involved in specific approval decisions when there is internal disagreement, but FDA said that would preclude some individuals from adjudicating a subsequent withdrawal proceeding.

Confirmatory Trials: US FDA Expectations Become Clearer Amid FDORA Flexibilities

 
• By Sue Sutter

Two recent accelerated approval guidances describe the FDA’s policy expectations for trial timeliness, but recognize the need for case-specific determinations. Regulatory actions in 2024 show the FDA is willing to delay application filing or approval over confirmatory trial status.

Japan In 2025: Policy Give, Pricing Take Set To Continue

 
• By Lisa Takagi

While Japan looks set to further improve policies to support ventures and ease market entry this year, these will contrast with ongoing reimbursement price controls.