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New CDER No. 2 May Impact FDA's Safety Monitoring Aspirations

 
• By Derrick Gingery

Patrizia Cavazzoni, CDER's new deputy director for operations, has safety surveillance background and wants to see FDA continue to grow its capabilities.

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Patrizia Cavazzoni's safety surveillance expertise may come in handy early in her tenure as the Center for Drug Evaluation and Research's deputy director of operations given the US FDA's desire to continue expanding the use of its Sentinel system.

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

 
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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

 
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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.

More from Agency Leadership

US FDA Not Industry’s ‘Sock Puppet,’ Ultragenyx’s Emil Kakkis Says

 
• By Sue Sutter

The biotech CEO said the Trump Administration’s treatment of FDA employees, including the HHS secretary’s comments about industry capture, are insulting to agency staff, but he is encouraged by FDA Commissioner Martin Makary’s talk of a new conditional approval pathway.

US FDA Commissioner’s Office Plans Involvement In Many Approvals In Potential Major Change

 
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FDA Commissioner Martin Makary's remarks that his special assistant Tracy Beth Høeg will "be involved in other approval procedures" besides Novavax's COVID-19 vaccine application could be a dramatic change in operations, potentially making the approval system unpredictable.

US FDA Commissioner Rejected Some Proposed Reorg Plans

 
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