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Listen "Drug Fix: Janet Woodcock retiring, Accelerated Approval Reform, US FDA Meeting Recording Policy"
Episode Synopsis
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
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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