Many Drug Approval Delays, Denials Could Be Prevented, FDA Study Shows
This article was originally published in The Pink Sheet Daily
Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.
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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.
Senate eyes a biomedical reform process that is simultaneously narrower and slower than the House’s 21st Century Cures Initiative; FDA’s Hamburg asks for ability to shape sponsor’s trial designs earlier and more regulatory science funding.
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.