Insulins as Drugs or Biologics in the USA: What Difference Does it Make and Why Does it Matter?
BioDrugs
; 33(5): 447-451, 2019 Oct.
Article
em En
| MEDLINE
| ID: mdl-31388968
ABSTRACT
The status of insulins in the USA is about to change as a regulatory matter. After 23 Mar 2020 they, and other hormone products previously regulated as drugs by the US Food and Drug Administration (FDA), even though biologics in science, will become biologics as a regulatory matter too and will be licensed under the Public Health Service Act. This has a number of ramifications for sponsors, patients, and their physicians.
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Produtos Biológicos
/
Aprovação de Drogas
/
Insulinas
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
BioDrugs
Assunto da revista:
ALERGIA E IMUNOLOGIA
/
GENETICA MEDICA
/
TERAPEUTICA
/
TERAPIA POR MEDICAMENTOS
Ano de publicação:
2019
Tipo de documento:
Article
País de afiliação:
Estados Unidos