Accelerated Approval and Expensive Drugs - A Challenging Combination.

Abstract

through its accelerated approval review track. This pathway, which dates back to the early 1990s, was designed as a response to the demand for faster drug development in the context of the HIV/AIDS crisis.1 Since then, the accelerated-approval program has expanded to include oncology products and drugs for other diseases, now accounting for about 10% of new… (More)
DOI: 10.1056/NEJMp1700446

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