US FDA's Breakthrough Program Needs Higher Standard For Comparators, NEJM Says

Harvard Medical School researchers call for inclusion of off-label drugs, accelerated approvals, and dietary supplements in the definition of 'existing therapies.'

SC1802_Lego Wall_658035112_1200.jpg

Three Harvard Medical School researchers are calling for the US FDA to broaden the definition of "existing therapies" in the criteria for the breakthrough therapy designation to raise the comparison baseline and increase the bar to qualify for the designation.

In a study published in the New England Journal of Medicine (NEJM) on April 11 that examines the first four...

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 R&D

More from Pink Sheet

Merck’s Keytruda Gains Medicare Negotiation Reprieve With Expanded Orphan Exemption

 
• By 

Bristol Myers Squibb’s Opdivo and Merck's Welireg also could benefit from the delay in Medicare price negotiation process eligibility.

US FDA’s Biologics Center Departures Grew Before More Than 100 RIFs Exited

 

The Center for Biologics Evaluation and Research saw departures far outnumber new hires in the second and third quarters of FY 2025, before more than 100 people left July 14 after the reduction-in-force was finalized.

US FDA Cancer Reviewers Heading For The Exits, Potentially Impacting Review Timelines

 

US FDA's cancer drugs division is feeling the effect of drug reviewer departures, despite efforts to keep them at the agency.