USFDA Accelerated Approval Mechanism - An Overview

Musmade, Prashant B and Janodia, Manthan D and Sreedhar, D and Ligade, Virendra S and Udupa, N (2009) USFDA Accelerated Approval Mechanism - An Overview. The Pharma Review. pp. 93-95.

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Abstract

In the process to extend the benefit to terminally ill patients, FDA has established the review process called as Accelerated Approval (AA) mechanism. This mechanism particularly aims to speed up the approval process for promising drugs that offer therapeutic advantage over the existing therapy particularly for serious and life threatening illnesses. The aim of FDA is to provide the patients with the advantages of the newer therapies; it does not always result to be a promising outcome. Many pharmaceutical companies have flouted FDA rules of continuing the post marketing surveillance studies after the grant of Accelerated Approval, and most of these companies have not submitted the post marketing surveillance report to FDA. This paper tries to identify the lacunae in this process of FDA of Accelerated Approval.

Item Type: Article
Subjects: Pharmacy > MCOPS Manipal > Pharmaceutical Quality Assurance
Pharmacy > MCOPS Manipal > Pharmacy Management
Depositing User: KMC Manipal
Date Deposited: 21 Apr 2012 06:52
Last Modified: 21 Apr 2012 06:52
URI: http://eprints.manipal.edu/id/eprint/76282

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