FDA's Generic Drug Program: Decreasing Time to Approval and Number of Review Cycles.
Implementation of the Generic Drug User Fee Amendments (GDUFA I) as part of the Food and Drug Administration Safety and Innovation Act of 2012 (Generic Drug User Fee Amendments. https://www.fda.gov/industry/fda-user-fee-programs/generic-drug-user-fee-amendments) successfully allowed the U.S. Food an...
| Publicado en: | Therapeutic Innovation & Regulatory Science Vol. 54; no. 4; pp. 758 - 764 |
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| Autores principales: | , , , , |
| Formato: | research tables/charts Journal Article |
| Publicado: |
Springer Nature
Jul2020
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| Acceso en línea: | Ver este registro en EBSCOhost |