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

Time To Simplify US FDA’s Expedited Pathways? It Won’t Be Simple

 
• By Michael McCaughan

Oncology center director Pazdur thinks it is time to streamline the expedited pathways for drug development in the US. Focusing on the goals, rather than the paperwork, is a good idea – but is easier said than done.

• Source: Alamy

US Food & Drug Administration Oncology Center of Excellence Director Richard Pazdur thinks the time is right to simplify the number of “expedited” pathways that FDA and drug sponsors use as part of the regulatory process.

Pazdur has emphasized that point as part of an initiative launched by Friends of Cancer Research last fall to build...

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 NME Reviews, Reduced Costs Combine To Lower US FDA Voucher Fee

 
• By Derrick Gingery

The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.

US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
• By Sue Sutter

Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.

US FDA Complete Response Letters Raise Confirmatory Evidence Shortfalls

 
• By Sue Sutter

The agency identified deficiencies in efficacy evidence intended to support results from a single adequate and well-controlled trial for orphan applications, including weaknesses in animal data and insufficient quantity and quality of biomarker data.

Diving Into US FDA’s Newly Public CRLs

 
• By Bridget Silverman

The Pink Sheet breaks down the data on the 89 complete response letters recently released by the FDA, including by type of application and problems noted.

More from Pathways & Standards

US FDA Complete Response Letters Offer ‘Path Forward’ To Approval

 
• By Sue Sutter

Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.

Blueprint For RWE: Aetion Execs Outline Real-World Data Role From Preclinical To Postmarketing

 
• By Bridget Silverman

Sponsors should systematically incorporate real-world evidence generation in all development programs, advises an epidemiology-forward “blueprint” Aetion executives developed.

US FDA Complete Response Letters Raise Confirmatory Evidence Shortfalls

 
• By Sue Sutter

The agency identified deficiencies in efficacy evidence intended to support results from a single adequate and well-controlled trial for orphan applications, including weaknesses in animal data and insufficient quantity and quality of biomarker data.