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US Food and Drug Administration utilization of postmarketing requirements and postmarketing commitments, 2009-2018
BACKGROUND/AIMS: The US Food and Drug Administration (FDA) outlines clinical studies as postmarketing requirements and commitments to be fulfilled following FDA approval of new drugs and biologics (“therapeutics”). Regulators have increasingly emphasized lifecycle evaluation of approved therapeutics...
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| Veröffentlicht in: | Clin Trials |
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| Hauptverfasser: | , , , , |
| Format: | Artigo |
| Sprache: | Inglês |
| Veröffentlicht: |
2021
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| Schlagworte: | |
| Online Zugang: | https://ncbi.nlm.nih.gov/pmc/articles/PMC8292154/ https://ncbi.nlm.nih.gov/pubmed/33863236 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1177/17407745211005044 |
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