1. Pink Sheet
  2. >>Product Reviews

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...

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
Start Free Trial

Already a subscriber?

More from Approvals

More from Product Reviews

EU 2025 Novel Drug Approvals See Conditional Authorizations Outpacing Previous Years

 
• By Neena Brizmohun

The six EU conditional marketing authorizations granted in the first half of 2025 alone equal the full count for 2024 and come close to the annual totals for the previous two years. Meanwhile, 1H 2025 saw a 30% rise in new active substance approvals compared to the same period last year.

New EU Drug Safety Rules Scrap Signal Detection Pilot, Boost Audit & Subcontracting Controls

 
• By Vibha Sharma

The European Commission has adopted new rules to cut red tape in pharmacovigilance, tighten oversight of outsourced drug safety activities, and ensure a balanced approach to signal detection, boosting both efficiency and patient safety.

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By Xu Hu

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.