US FDA Guidance ‘Best Practices’: How Much Room For Improvement?

Outlining ideas to improve the efficiency of its guidance development policy fulfills a legislative mandate, but US FDA also wants credit for the strides it has already taken.

arrows
• Source: Shutterstock

The US Food & Drug Administration is responding to a Congressional directive to improve its guidance development process with some ideas for enhancements – and a lot of data to suggest that it has already made significant strides.

The agency released a draft report outlining potential changes to its Good Guidance Practices, including the possibility of issuing...

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 Approval Standards

More from Pathways & Standards

Early Support For EMA’s Trial Of US-Style Standards In Non-Clinical Reviews

 
• By 

An ongoing proof-of-concept study by the European Medicines Agency testing the use of US-style standards for submitting non-clinical raw data in marketing applications has received positive feedback from both industry and regulatory assessors so far.

New EU Approvals

 

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include two new products, one of which is Tepezza, Amgen's treatment for moderate to severe thyroid eye disease.

America Next: Most Novel Agents With July Goal Dates Have Been Approved Overseas

 

The US FDA will not be in its usual position as the first regulator to approve novel drugs, with only one of the six novel candidates on the July user fee calendar seeking its first approval worldwide in the US