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Back To Normal? US FDA Schedules In-Person Meeting But Pauses Non-COVID Guidance Development

 
• By Derrick Gingery

As the agency and country plot the steps to reopening, a full resumption of activities still seems a long way off.

Compass and keyboard
FDA's recent actions seem to be aiming at different points on the compass as it assesses how the pandemic is affecting operations.

Those in the pharma industry looking for any sign that we soon will be returning to normal life may have been encouraged by a recent Federal Register notice from the US Food and Drug Administration.

The agency announced a meeting on modernizing its data strategy was rescheduled for 30 June and will be held in-person...

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Base Benefit-Risk Decisions On Data, Not Opinion And Passion, CDER’s Tidmarsh Says

 
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US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

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US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 
• By Derrick Gingery

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 
• By Sarah Karlin-Smith

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.

Quotable: Top Experts On Policy Hot Topics

 
• By Anabel Costa-Ferreira

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