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
Regulatory News ODAC votes overwhelmingly in support of PD-L1 expression as predictive biomarker for efficacy of checkpoint inhibitorsVote applies across drugs and indications September 27, 2024Vol.50 No.36By Jacquelyn Cobb
Regulatory News Melanoma investigators invite FDA to publicly discuss approval endpoints and crossover designThe agency accepts the invitation September 20, 2024Vol.50 No.35By Paul Goldberg
Regulatory News ODAC vote will likely lead to three-arm and four-arm designs–and pragmatic trials–for perioperative indications July 26, 2024Vol.50 No.30By Jacquelyn Cobb and Paul Goldberg
Regulatory News ODAC unanimously upholds MRD as early endpoint across all settings in multiple myeloma April 26, 2024Vol.50 No.17By Jacquelyn Cobb
