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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Detalles Bibliográficos
Autores principales: Chahal, Harinder Singh, Mukherjee, Sanjana, Sigelman, Daniel W., Temple, Robert
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Medical Association 2021
Materias:
Original Investigation
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7885096/
https://www.ncbi.nlm.nih.gov/pubmed/33587091
http://dx.doi.org/10.1001/jamainternmed.2020.8866

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