Understanding the drug development process.
Inflamm Bowel Dis
; 11 Suppl 1: S13-6, 2005 Nov.
Article
em En
| MEDLINE
| ID: mdl-16254477
ABSTRACT
In the United States, new drug development is a complex, highly regulated process that often involves academic institutions, the pharmaceutical industry, and government agencies. Much of the primary and clinical research conducted in the United States is funded by the National Institutes of Health. The Food and Drug Administration (FDA) provides regulatory review and oversight of the drug development process. The Investigational New Drug application is the primary mechanism that the FDA uses to regulate clinical testing in humans. A New Drug Application summarizing all of the data necessary to perform risk/benefit analysis of the new drug is submitted to the FDA for review and approval once sufficient testing has been completed. Recent research into the pathogenesis of inflammatory bowel disease has yielded numerous drug targets resulting in a multitude of molecules and biologic agents under varying stages of development and a consequent need for clinical testing. A thorough understanding of the regulatory development process and the National Institutes of Health funding process is necessary for any investigator involved in clinical trials.
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Base de dados:
MEDLINE
Assunto principal:
United States Food and Drug Administration
/
Doenças Inflamatórias Intestinais
/
Aprovação de Drogas
Limite:
Humans
País/Região como assunto:
America do norte
Idioma:
En
Revista:
Inflamm Bowel Dis
Assunto da revista:
GASTROENTEROLOGIA
Ano de publicação:
2005
Tipo de documento:
Article
País de afiliação:
Estados Unidos