Early Developments in the Regulation of Biologics.
Food Drug Law J
; 71(4): 544-607, 2016.
Article
em En
| MEDLINE
| ID: mdl-29140646
ABSTRACT
This article is a history of the policy positions and legal interpretations adopted by the Public Health Service (PHS) under the 1902 Biologics Control Act. PHS generally interpreted the scope of the Act narrowly because it lacked authority to deny marketing licenses for ineffective biologics and wanted to minimize the number of worthless drugs with the imprimatur of a governmental license. In addition, PHS implemented important regulatory strategies not expressly authorized by the Act.
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Coleções:
01-internacional
Contexto em Saúde:
4_TD
Base de dados:
MEDLINE
Assunto principal:
Produtos Biológicos
/
Controle de Medicamentos e Entorpecentes
Tipo de estudo:
Prognostic_studies
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Food Drug Law J
Ano de publicação:
2016
Tipo de documento:
Article