Mandatory FDA Review Of Pivotal Trial Protocols Urged In JAMA
This article was originally published in The Pink Sheet Daily
Dartmouth researchers say that although FDA recommendations can strengthen study designs and improve outcome measures, sponsors often don’t follow agency’s advice or don’t even seek input in Phase III design.
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However, FDA allows manufacturers more leeway in providing additional data or new analyses to better understand a safety issue than an efficacy concern, according to a Health Affairs study of novel drugs approved after multi-cycle reviews.
Although drugs on the FDASIA-created expedited pathway may promise more than they can deliver, it will be difficult to reduce demand for such treatments awarded the designation, Boston researchers predict in a NEJM piece.
Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.