FDA Accelerated approval – expedited program for serious conditions (from Catapult's regulatory round-up for December 2024)

FDA has issued a draft guidance to provide information on FDA’s policies and procedures for accelerated approval as well as threshold criteria for whether a drug is a candidate for accelerated approval. This guidance also describes the procedures for expedited withdrawal of approval of a product approved under accelerated approval and the revisions Congress made through the Consolidated Appropriations Act, 2023 (Public Law 117-328). The deadline for comments is 4th February 2025. Published o...