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.