Pink Sheet reporters and editor discuss FDA Principal Deputy Commissioner Janet Woodcock’s place in the pantheon of FDA leaders (:27), an agency meeting with stakeholders on puberty blockers (23:55), and a new boxed warning for CAR-T therapies (35:42). More On These Topics From The Pink Sheet Immortalizing Janet Woodcock: https://pink.citeline.com/PS149666/Immortalizing-Janet-Woodcock On Puberty Blockers, FDA Is In ‘Listen Only’ Mode – For Now: https://pink.citeline.com/PS149679/On-Puberty-Blockers-FDA-Is-In-Listen-Only-Mode--For-Now CAR-Ts Getting Boxed Warning On Secondary Malignancies Despite Sponsor Causation Questions: https://pink.citeline.com/PS149673/CAR-Ts-Getting-Boxed-Warning-On-Secondary-Malignancies-Despite-Sponsor-Causation-Questions Kite’s Tecartus Boxed Warning Will More Closely Resemble Other CAR-Ts After FDA Changes Course: https://pink.citeline.com/PS149680/Kites-Tecartus-Boxed-Warning-Will-More-Closely-Resemble-Other-CAR-Ts-After-FDA-Changes-Course

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

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