FDA Accelerated approval – expedited program for serious conditions (from Catapult's regulatory round-up for December 2024)
Year: 2025
Type: other
Abstract: FDA has issued a draft guidance to provide information on FDA’s policies and procedures for accelerated approval as well as threshold criteria for whether a drug is a candidate for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...
DOI: 10.58079/13ay0
Author: Adelage
Language: English
Subfield: Economics and Econometrics
Domain: Social Sciences
Open Access status: green
OpenAlex ID: W6936773046
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