Not So Fast On Expedited Approvals, Drug Safety Researchers Caution

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 to a situation in which many innovative drugs are more rapidly approved after a small trial in a narrow patient population, with extensive additional testing conducted after approval,” state

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from Approvals

More from Product Reviews