Regulatory News Cyber-iconoclast Vinay Prasad named head of FDA’s CBERAn oncologist, Prasad has criticized accelerated approval, next-gen sequencing, and targeted therapies May 09, 2025Vol.51 No.18By Claire Marie Porter
Regulatory News Makary vows to speed up drug approvals and end FDA’s “cozy” relationship with industryCommissioner promises to protect scientific integrity while bringing in “fresh” MAHA ideas April 25, 2025Vol.51 No.16By Claire Marie Porter
Regulatory News RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”Whistleblowers will be “honored” April 18, 2025Vol.51 No.15By Jacquelyn Cobb
Regulatory News Backlog of work grows at NIH as staff members are being hounded to quit March 14, 2025Vol.51 No.10By Paul Goldberg, Jacquelyn Cobb and Claire Marie Porter
Regulatory News Trump et al. focus on NIH, cancer—and how peer review is done March 07, 2025Vol.51 No.09By Jacquelyn Cobb, Claire Marie Porter and Paul Goldberg
Regulatory News Ready or not, AI-based decision support tools are entering oncology clinicsRegulators and health systems must adapt November 15, 2024Vol.50 No.43By McKenzie Prillaman
Regulatory News At his 25-year “anniversary party,” Pazdur invites Califf and past FDA commissioners to talk about political interference November 01, 2024Vol.50 No.41By Claire Marie Porter
Regulatory News FDA extends shelf-life for IV fluids in shortage after Hurricane Helene November 01, 2024Vol.50 No.41By Claire Marie Porter
Regulatory News ODAC votes decisively in support of PD-L1 expression as predictive biomarker for checkpoint inhibitorsVote may lead to rollback of some indications held by BMS and Merck October 04, 2024Vol.50 No.37By Jacquelyn Cobb
Regulatory News New FDA mandate to tell patients whether their breasts are “dense” or “not dense” baffles doctorsProblem: “Breast density is in the eye of the mammographer” September 27, 2024Vol.50 No.36By Claire Marie Porter
