Why Drugs Get Delayed: Blame It On Safety Concerns, Researchers Say
This article was originally published in The Pink Sheet Daily
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.
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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.
Agency reports preventable deficiencies, including failure to select optimal drug doses and suitable study endpoints, account for many drug rejections, approval delays.
Advisory committee says planned waivers for molecularly targeted studies should take into account comparative adult efficacy and toxicity data for multiple drugs in the same class, as well as differences in product attributes, such as route of administration and dosing schedule; unmet clinical need should have less influence on decision to grant waivers, panelists said.