Protecting the public's health through the application integrity policy.
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.
Division of Manufacturing and Product Quality, Office of Compliance, Center for Drug Evaluation and Research, USA.
Paula R
PR
Katz
D017277:Drug Approval; D016568:Drugs, Generic; D006291:Health Policy; D006801:Humans; D011634:Public Health; D014481:United States; D014486:United States Food and Drug Administration
D016568:Drugs, Generic