Association Between Preapproval Confirmatory Trial Initiation and Conversion to Traditional Approval or Withdrawal in the FDA Accelerated Approval Pathway
| Autor: | Mahnum Shahzad, Huseyin Naci, Anita K. Wagner |
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| Rok vydání: | 2023 |
| Předmět: | |
| Zdroj: | JAMA. 329:760 |
| ISSN: | 0098-7484 |
| Popis: | This study examines the Food and Drug Administration’s accelerated approval pathway and whether preapproval initiation was associated with faster conversion to traditional approval or withdrawal for drugs with nononcology indications. |
| Databáze: | OpenAIRE |
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