Regulatory News Vinay Prasad, oncology’s gadfly-turned-CBER-director, will leave FDA (again) March 13, 2026Vol.52 No.10By Claire Marie Porter
Regulatory News Prasad’s rule by fiat spilled into accelerated approvals in hematology and oncologyAtara Bio’s Cokey Nguyen: Normally, FDA wants to help us succeed. Now, “we’re getting new guidance at the last minute and it’s not helping.” March 13, 2026Vol.52 No.10By Jacquelyn Cobb
Regulatory News CBER Director Vinay Prasad sidelined staff to jettison Moderna’s mRNA flu shot February 13, 2026Vol.52 No.06By Claire Marie Porter
Regulatory News FDA withdraws proposed rule for asbestos testing in talc-based cosmeticsIt’s anyone’s guess whether the agency is preparing to strengthen or relax talc regulation December 12, 2025Vol.51 No.45By Claire Marie Porter
Regulatory News ESMO publishes guidances on AI tools for clinicians, patients, and researchersSays one author: “We think there should be some degree of human oversight, otherwise, they can go completely rogue and nobody notices.” December 12, 2025Vol.51 No.45By Sara Willa Ernst
Regulatory News Pazdur leaves FDA after 25-year career that shaped the agency’s oncology regulationsBIO calls for the end of “constant turmoil,” urges the administration to “right the ship” December 05, 2025Vol.51 No.44By Paul Goldberg
Conversation with The Cancer LetterRegulatory News Richard Pazdur, a respected insider with a plan to reengineer FDA, steps in as CDER director November 14, 2025Vol.51 No.42By Paul Goldberg
Regulatory News FDA to remove black box warnings on hormone therapy for menopauseTrump-era “gold standard science” is not to be confused with gold standard of scientific evidence November 14, 2025Vol.51 No.42By Claire Marie Porter
Regulatory News CDER Director Tidmarsh quits amid inspector general probe of his “personal conduct”Cancer advocates express concern about comments that signal trouble for accelerated approval November 07, 2025Vol.51 No.41By Claire Marie Porter and Paul Goldberg
Regulatory News Friends study points to ctDNA’s potential to serve as an intermediate endpoint in NSCLCctMoniTR project aims to improve efficiency in development of intermediate endpoints October 24, 2025Vol.51 No.39By Jacquelyn Cobb
