Not So Fast On Expedited Approvals, Drug Safety Researchers Caution
This article was originally published in The Pink Sheet Daily
Analysis finds that expedited pathways – priority review, accelerated approval and fast track status – bring drugs to market faster, but cautions that pushing safety evaluation to the post-marketing setting carries its own risks, JAMA Internal Medicine article finds.
You may also be interested in...
An FDA study evaluating NMEs by level of innovation finds level first-in-class approvals to be consistent, and approvals after the study period reinforce “encouraging” findings. Analysis says new metric should be basis for assessment of programs created by FDASIA to speed development of innovative products.
Presidential advisory panel makes eight recommendations to improve innovation in drug discovery, development and evaluation; calls for broad partnership of stakeholders to accelerate therapeutics, $40 million annual appropriations for FDA’s Sentinel System.
In remarks fleshing out the ‘EUA Plus’ guidance before it became a political football, Operation Warp Speed’s Slaoui said that an FDA analysis concluded that 90% of adverse events related to vaccination take place within the first 42 days.