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Contents of US Food and Drug Administration Refuse-to-File Letters for New Drug Applications and Efficacy Supplements and Their Public Disclosure by Applicants
IMPORTANCE: Before reviewing drug applications, the US Food and Drug Administration (FDA) conducts “filing reviews” to assess whether they are complete enough for full review. If the applications are incomplete, the FDA issues refuse-to-file (RTF) letters identifying deficiencies. The FDA does not m...
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| Publicado no: | JAMA Intern Med |
|---|---|
| Main Authors: | , , , |
| Formato: | Artigo |
| Idioma: | Inglês |
| Publicado em: |
American Medical Association
2021
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| Assuntos: | |
| Acesso em linha: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7885096/ https://ncbi.nlm.nih.gov/pubmed/33587091 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1001/jamainternmed.2020.8866 |
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