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

US FDA Considers Making More Guidance Final Without Public Comment

 
• By Derrick Gingery

Increased use of the ‘immediate implementation’ provision in the agency’s Good Guidance Practices could help reduce stakeholder uncertainty.

guidance
To use the ‘immediately implementation’ provision, public comment has to be deemed not feasible or inappropriate. • Source: Shutterstock

Sponsors and stakeholders soon could see more new US Food and Drug Administration guidances that skip the public comment process prior to their finalization in an effort to speed publication of agency thinking.

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.