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

COPD Patient-Reported Outcome Questionnaire Is Early Example of FDA Drug Development Tool “Approval” Process

 
• By Jacqueline Fitton and Michael McCaughan

FDA finalizes the "qualification process for drug development tools." The topic won't get as much attention as Breakthrough Therapy or Accelerated Approval, but the head of the drug center thinks this is a very big deal. A COPD outcomes assessment is an early example of the process in action.

The Center for Drug Evaluation & Research publishes a lot of guidances over the course of a year. Some are announced with great fanfare, most draw little attention outside of the directly affected product category, and a few may generate more attention than FDA wished.

But on January 6, FDA finalized a guidance that CDER Director Janet Woodcock has publicly said deserves a lot more...

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

New EU Approvals

 
• By Neena Brizmohun

The Pink Sheet's list of EU centralized approvals of new active substances has been updated to include three new products, one of which is Rezdiffra, Madrigal Pharmaceuticals’s treatment for metabolic dysfunction-associated steatohepatitis.

Navigating Rare Disease Submissions: Minoryx Stresses Early EMA Engagement

 
• By Manas Mishra

Minoryx explained to Pink Sheet why it believes its resubmission for leriglitazone stands a stronger chance of approval, and highlighted the value of early dialogue with the regulators when it comes to rare diseases, where the understanding of the natural history and outcomes is often limited.

Oncology: Plan Ahead To Rule Out Harm When Survival Not The Endpoint, US FDA Says

 
• By Michael McCaughan

The FDA recommended sponsors plan ahead for potential issues if overall survival is not feasible as a primary or secondary efficacy endpoint in clinical trials and must be analyzed as a safety outcome.

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

More from Pathways & Standards

Selective Safety Data Collection In Clinical Trials: Adoption Lags Despite Benefits, US FDA Says

 
• By Manas Mishra

Lack of awareness is limiting use of guidelines that simplify safety reporting for some late-stage trials, FDA says, while also highlighting wins. Boehringer experienced mixed results, while Novartis, Lilly, and Merck were more successful, and Roche should have probably tried, white paper suggests.

COVID Vaccine Makers Should Be More Proactive On Study Designs, Countering Misinformation

 
• By Sue Sutter

Manufacturers should use nontraditional, randomized study designs and rigorous observational approaches to counter concerns about safety and effectiveness in low-risk populations, while also doing more to respond to the public’s questions about mRNA technology, legal and medical experts said.

US FDA’s Latest Review Of Stealth’s Elamipretide Will Move With Speed

 
• By Kevin Grogan

The agency is expected to give its final verdict on the Barth syndrome drug by the end of September. Stealth is seeking accelerated approval based on the path forward outlined in the FDA's May 2025 complete response letter.