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...

وصف كامل

التفاصيل البيبلوغرافية
الحاوية / القاعدة:	BMJ Oncology
المؤلفون الرئيسيون:	Steven Joffe, Ronac Mamtani, Ravi B Parikh, Holly Fernandez Lynch, William J Ferrell, Martin Kurian, Ernesto Ulloa Perez, Rebecca Hubbard
التنسيق:	مقال
اللغة:	الإنجليزية
منشور في:	BMJ Publishing Group 2025-05-01
الوصول للمادة أونلاين:	https://bmjoncology.bmj.com/content/4/1/e000659.full

مواد مشابهة

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