Pink Sheet reporters and editors discuss US FDA Principal Deputy Commissioner Janet Woodcock’s legacy as her retirement approaches (:42), the stance of the FDA’s oncology division on confirming benefit after an accelerated approval (16:59), and why formal meetings between the agency and sponsors cannot be recorded (36:51). More On These Topics From The Pink Sheet With Woodcock’s Retirement, US FDA Loses A Renaissance Woman: https://pink.citeline.com/PS149368/With-Woodcocks-Retirement-US-FDA-Loses-A-Renaissance-Woman Confirmatory Trial Plan For Acrotech’s Folotyn, Beleodaq Needs Rethinking, FDA Panel Says: https://pink.citeline.com/PS149361/Confirmatory-Trial-Plan-For-Acrotechs-Folotyn-Beleodaq-Needs-Rethinking-FDA-Panel-Says FDA Panel To Consider Strategies For Timely Completion Of Accelerated Approval Confirmatory Trials: https://pink.citeline.com/PS149353/FDA-Panel-To-Consider-Strategies-For-Timely-Completion-Of-Accelerated-Approval-Confirmatory-Trials Accelerated Approval: US FDA Writing Guidance On What ‘Ongoing’ Means For Confirmatory Trials: https://pink.citeline.com/PS149359/Accelerated-Approval-US-FDA-Writing-Guidance-On-What-Ongoing-Means-For-Confirmatory-Trials Accelerated Approval: Acrotech’s Confirmatory Trial For Folotyn, Beleodaq More Than A Decade Behind Schedule: https://pink.citeline.com/PS149342/Accelerated-Approval-Acrotechs-Confirmatory-Trial-For-Folotyn-Beleodaq-More-Than-A-Decade-Behind-Schedule Minutes Matter: Why The US FDA Refuses To Record Formal Meetings: https://pink.citeline.com/PS149310/Minutes-Matter-Why-The-US-FDA-Refuses-To-Record-Formal-Meetings

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“What did the council decide on item 42?” — answered with the speaker and the moment.

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