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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| Main Authors: | , , , , , , , |
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2025-05-01
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| Series: | BMJ Oncology |
| Online Access: | https://bmjoncology.bmj.com/content/4/1/e000659.full |
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