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Not So Fast On Expedited Approvals, Drug Safety Researchers Caution

 
• By Bridget Silverman

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.

Shifting evidence collection from pre-approval to the post-market setting successfully brings new therapies to patients sooner, but at a cost in safety evaluation, researchers conclude in an analysis published online Oct. 28 in JAMA Internal Medicine.

“The testing of new drugs has shifted from a situation in which most testing was conducted prior to initial approval...

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