EPISODE · Dec 5, 2025 · 28 MIN
Drug Fix: Understanding the US FDA’s CDER Leadership Shuffle
from Citeline Podcasts · host Norstella
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/
What this episode covers
Pink Sheet Executive Editor Derrick Gingery, Senior Writer Sarah Karlin-Smith and Editor-in-Chief Nielsen Hobbs break down the pending retirement of Center for Drug Evaluation and Research Director Richard Pazdur and appointment of Tracy Beth Høeg as the interim replacement (4:51), including the potential impact on sponsors (15:46). They also discuss whether Høeg will take time to learn CDER operations before making changes (19:38), as well as the possibility of yet another CDER director being hired in the coming weeks or months (23:18). More On These Topics From The Pink Sheet US FDA Faces Another Leadership Crisis As Drugs Center Director Richard Pazdur Retires: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/breaking-us-fda-cder-director-richard-pazdur-retiring-SUPZZ4JEQ5GVHEEH4RPDLCNIBY/ Tracy Beth Høeg Named New Acting US FDA CDER Director: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/tracy-beth-hoeg-named-new-acting-us-fda-cder-director-3AYJZJAMBVG6HNPX3FJ7IBCDHQ/ US FDA Sending Pazdur Back To Oncology Office: https://insights.citeline.com/pink-sheet/agency-leadership/us-fda/us-fda-sending-pazdur-back-to-oncology-office-KVBDIDT2RVF4JAZ7FCZHN46XXU/
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Drug Fix: Understanding the US FDA’s CDER Leadership Shuffle
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