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Pink Sheet Podcast: CDER Director Retires, US FDA Guidance ‘Blizzard,’ Rare Pediatric Disease Program Hangs On

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement, the importance of the large bolus of guidance documents that the FDA released 6 January, and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed.

Pink Sheet podcast
The bolus of guidances released 6 January cement FDA thinking on many subjects. • Source: Citeline/Shutterstock

Pink Sheet Executive Editor Derrick Gingery, Senior Editor Sue Sutter and Editor-in-Chief Nielsen Hobbs discuss Patrizia Cavazzoni’s legacy as Center for Drug Evaluation and Research Director in light for upcoming retirement (:32), the more than two dozen guidances that the US Food and Drug Administration issued in one day and why the move was unusual (12:42), as well as the reasons for the agency continuing to review and grant rare pediatric disease designation requests even though the program expired in December 2024 (18:48).

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