The Integrated Review: FDA Modernizes the Review of New Drug Marketing Applications.
Ther Innov Regul Sci
; 55(3): 467-472, 2021 05.
Article
en En
| MEDLINE
| ID: mdl-33236259
ABSTRACT
New Drug Applications and Biologics Licensing Applications submitted to the US Food and Drug Administration (FDA) are reviewed by an interdisciplinary team of regulatory scientists that includes medical officers, clinical pharmacologists, toxicologists, statisticians, and drug labeling experts. Upon review of an applicant's submitted evidence from nonclinical studies, clinical trials, and manufacturing capabilities, the review team evaluates the benefits and risks of the drug and makes a scientifically-informed decision. As part of a multi-year, multi-phase New Drugs Regulatory Program Modernization effort, the FDA has recently redesigned how it reviews and documents its decisions with regard to marketing applications. This article describes the origins and rationale of the new Integrated Assessment process and Integrated Review document, summarizes how these differ from the FDA's traditional review of marketing applications, and discusses what industry can expect from a modernized drug review.
Palabras clave
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Preparaciones Farmacéuticas
/
Mercadotecnía
Tipo de estudio:
Prognostic_studies
País/Región como asunto:
America do norte
Idioma:
En
Revista:
Ther Innov Regul Sci
Año:
2021
Tipo del documento:
Article
País de afiliación:
Estados Unidos