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- W2337352891 abstract "In the process to extend the benefit to terminally ill patients, FDA has established the review process called asAccelerated 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. Manypharmaceutical 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." @default.
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- W2337352891 date "2009-03-01" @default.
- W2337352891 modified "2023-09-24" @default.
- W2337352891 title "USFDA Accelerated Approval Mechanism - An Overview" @default.
- W2337352891 hasPublicationYear "2009" @default.
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