1. Pink Sheet
  2. >>Pathways & Standards
  3. >>Approval Standards

FDA’s Jenkins On “Progressive Approval”: Don’t Lower The Efficacy Bar

 
• By Sue Sutter

Office of New Drugs director says a “weight of the evidence” standard will not provide reasonable assurance of drug efficacy and safety.

There are plenty of unknowns surrounding the concept of a “progressive approval” system, but one thing is clear in the eyes of FDA Office of New Drugs Director John Jenkins – there should be no lowering of the efficacy bar.

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 Approval Standards

More from Pathways & Standards

Another Regeneron CRL Prompts Regulatory Operations Questions

 
• By Alaric DeArment

CEO Len Schleifer said during the company’s first quarter earnings call that most of the complete response letters the company has received related to third-party suppliers, not efficacy or safety.

New EU Filings

 
• By Neena Brizmohun

Plozasiran, Arrowhead Pharmaceuticals' treatment for familial chylomicronemia syndrome, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

US FDA Commissioner Rejected Some Proposed Reorg Plans

 
• By Elizabeth Orr

FDA Commissioner Martin Makary said in an interview that he will use the current structure to reform the agency. He also plans to address employee morale.