1. Scrip
  2. >>Business

FDA To Join The 'Real World' Under PDUFA VI

 
• By Donna Young

Under round six of the user fee agreement with industry, the FDA is pledging to explore the use of real-world evidence, strengthen the patient's voice in the drug review process and boost the agency's postmarketing surveillance abilities.

PDUFA VI letter

The FDA has decided to join the real world next year – or at least, explore it, in terms of what type of data it will consider from innovator drug makers.

Under negotiations with the biopharmaceutical community for the sixth round of the reauthorization of the Prescription Drug User Fee Act...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Scrip 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 Business

Stock Watch: On Q1 Vaccine Sales And Measles Outbreaks

 
• By Andy Smith

A recent study suggested that measles could become endemic in the US due to low vaccination rates. However, first-quarter vaccine sales offered a more nuanced picture.

Merck & Co.’s RSV Antibody Approved In US In Time To Compete With Blockbuster Beyfortus

 
• By Mandy Jackson

The US FDA approved Merck’s Enflonsia (clesrovimab) to prevent RSV in newborns and infants on the same day Sanofi assured that it would ship Beyfortus in time for the 2025-2026 RSV season.

Metsera’s Amylin Analog Stars In Obesity Phase I

 
• By Joseph Haas

Intended as obesity monotherapy and for combination with the firm’s GLP-1 analog, MET-0233i showed best-in-class efficacy with placebo-like tolerability at low doses.

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 
• By Jessica Merrill

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

More from Scrip

Merck & Co.’s Enlicitide Poised To Be First Oral PCSK9 Inhibitor To Market

 
• By Jessica Merrill

The company announced positive data from two Phase III trials testing the cholesterol-lowering medicine.

Sanofi Cements RSV Dominance As Merck & Co. Rival Awaits FDA D-Day

 
• By Kevin Grogan

The French company will start shipping its blockbuster shortly to meet expected strong demand in the 2025–26 RSV season.

Pipeline Watch: ASCO Dominates Phase III Readouts

Pipeline Watch is a weekly snapshot of selected late-stage clinical trial events and approvals announced by pharmaceutical and biotech companies at medical and industry conferences, in financial and company presentations, and in company releases and statements.