Abbreviated New Drug Applications: Generic Drug User Fee Amendments Act Analysis of Application Quality Metrics.
Ther Innov Regul Sci
; 53(5): 696-700, 2019 09.
Article
em En
| MEDLINE
| ID: mdl-30360656
ABSTRACT
Implementation of the first Generic Drug User Fee Amendments of 2012 (GDUFA I) provided funding to the US Food and Drug Administration (FDA) for modernizing review of the FDA/CDER Generic Drug Program. Under GDUFA I, FDA agreed to reduce the backlog of pending generic Abbreviated New Drug Applications (ANDAs), improve the efficiency of generic drug review, and reduce the number of review cycles with the goal of reducing overall time to approval. This study presents a preliminary analysis of initial filing and regulatory first actions on ANDAs during GDUFA I cohort year 3 (CY3) and cohort year 4 (CY4). It highlights initial successes and areas of improvement in the ANDA review process for both FDA and ANDA applicants to improve the efficiency of providing the public with high-quality, affordable generic drugs.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Aprovação de Drogas
/
Legislação de Medicamentos
Tipo de estudo:
Prognostic_studies
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Ther Innov Regul Sci
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Estados Unidos