Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011–2023: a cross-sectional analysis

Specificity of Food and Drug Administration postmarketing requirements and associations with timely submissions and regulatory decisions for oncology accelerated approvals, 2011–2023: a cross-sectional analysis

Objectives To assess the specificity of postmarketing requirement (PMR) statements and associations between PMR statement specificity and PMR study characteristics, timeliness and regulatory decisions.Methods and analysis This was a cross-sectional analysis of publicly available Food and Drug Admini...

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Bibliographic Details
Main Authors: Steven Joffe, Ronac Mamtani, Ravi B Parikh, Holly Fernandez Lynch, William J Ferrell, Martin Kurian, Ernesto Ulloa Perez, Rebecca Hubbard
Format: Article
Language:English
Published: BMJ Publishing Group 2025-05-01
Series:BMJ Oncology
Online Access:https://bmjoncology.bmj.com/content/4/1/e000659.full
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