Regulatory News ODAC considers the first application based wholly on RWE methodology—and nixes it unanimously November 04, 2022Vol.48 No.40By Paul Goldberg
Regulatory News Pazdur at FDA-ASCO workshop: Failure to optimize the dose is akin to building a house on quicksand May 06, 2022Vol.48 No.18By Alice Tracey
Regulatory News FDA’s Brian Booth: “We need to reconsider our approach to dose selection” April 29, 2022Vol.48 No.17By Alice Tracey
Regulatory News As part of Cancer Moonshot, FDA seeks to prohibit menthol cigarettes, flavored cigars April 29, 2022Vol.48 No.17By Paul Goldberg
Regulatory News In a 14:1 vote, ODAC nixes a PD-1 drug developed in China; data not generalizable to U.S. population February 11, 2022Vol.48 No.06By Paul Goldberg and Alice Tracey
Conversation with The Cancer LetterRegulatory News FDA says it had no input as companies developed checkpoint inhibitors in China February 04, 2022Vol.48 No.05By Paul Goldberg
Regulatory News FDA cancels second ODAC in a row as two accelerated approval drugs are yanked by sponsors (and one still dangles) December 03, 2021Vol.47 No.44By Alice Tracey
