1.
Food Drug Law J
; 65(3): 539-43, iii, 2010.
Artículo
en Inglés
| MEDLINE
| ID: mdl-24479240
RESUMEN
FDA's recent use of the Application Integrity Policy (AIP), most notably in the ongoing Ranbaxy matter, has created interest in the policy. The article discusses actions CDER's Office of Compliance is currently undertaking to raise awareness of the AIP and establish the Office of Compliance as CDER's clearing-house for integrity issues. The article reviews a current AIP case and discusses how the use of the AIP can protect public health.
Asunto(s)
Aprobación de Drogas , Salud Pública , Medicamentos Genéricos , Política de Salud , Humanos , Estados Unidos , United States Food and Drug Administration
2.
MGMA Connex
; 12(7): 34-7, 2012 Aug.
Artículo
en Inglés
| MEDLINE
| ID: mdl-22937595
3.
AAPS J
; 18(2): 528-43, 2016 Mar.
Artículo
en Inglés
| MEDLINE
| ID: mdl-26860627