Drug Fix: CDER Director Retires, US FDA Guidance ‘Blizzard,’ Rare Pediatric Disease Program Hangs On

Citeline Podcasts

Pink Sheet editors discuss Center for Drug Evaluation and Research Director Patrizia Cavazzoni’s surprising retirement announcement (:32), the importance of the large bolus of guidance documents that the FDA released 6 January (12:42), and the FDA’s decision to continue reviewing and granting rare pediatric disease designations even though the program lapsed (18:48). More On These Topics From The Pink Sheet Digging Through The US FDA Guidance Blizzard: https://insights.citeline.com/pink-sheet/legislation/elections/digging-through-the-us-fda-guidance-blizzard-TR6LKKXLZ5C5ZG5HUYDJ6XJO3M/ Artificial Intelligence: US FDA Outlines 7 Steps To Establishing Model Credibility: https://insights.citeline.com/pink-sheet/advanced-technologies/ai/artificial-intelligence-us-fda-outlines-7-steps-to-establishing-model-credibility-ZZTAXYUP3BDKPKLF6CVECQYO7M/ Accelerated Approval: US FDA Explains When A Confirmatory Trial Is ‘Underway’: https://insights.citeline.com/pink-sheet/product-reviews/post-marketing-regulation-and-studies/accelerated-approval-us-fda-explains-when-a-confirmatory-trial-is-underway-YP2DRCCKFBHJHOJ7K7LKH2AX4U/ Off-Label Communications: US FDA Clarifies Safe Harbor For Firm-Generated Presentations: https://insights.citeline.com/pink-sheet/compliance/marketing-and-advertising/off-label-communications-us-fda-clarifies-safe-harbor-for-firm-generated-presentations-DEDRJWWNWBAUJPTEVI2GLHGI4M/ US FDA Still Reviewing Rare Pediatric Disease Designation Requests Despite Program Lapse: https://insights.citeline.com/pink-sheet/rare-diseases/us-fda-still-reviewing-rare-pediatric-disease-designation-requests-despite-program-lapse-EJSANI3SL5GATG66ZMVYVCME4E/