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

From ‘Accelerate’ To ‘Confirm’: US FDA Launches Transparency Program On Cancer Drug Approvals

 
• By Sue Sutter

Oncology Center of Excellence’s Project Confirm, formerly known as Project Accelerate, is intended to promote transparency of outcomes related to cancer drug accelerated approvals; initiative includes searchable databases on the status of oncology/hematology indications.

Confirm
FDA's oncology center is emphasizing the "confirm" part of the accelerated approval pathway in a new transparency project. • Source: Alamy

The US FDA Oncology Center of Excellence’s new transparency initiative on accelerated approvals is emphasizing the “confirm” part of the expedited pathway.

Project Confirm joins an ever-growing list of formal OCE initiatives, with this one aimed at promoting the transparency of outcomes...

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 Review Pathways

Project Orbis: 2025 Shaping Up To Be A Strong Year For Canadian Approvals

 
• By Eliza Slawther

Health Canada has approved four new drugs and 12 label variations so far this year via Project Orbis, a combined figure that already exceeds the annual approval figures for the two previous years. The agency explains the factors that impact annual approvals and highlights the pathway’s benefits.

Project Orbis: Annual UK Approvals Down Since 2022, But MHRA Touts Advantages

 
• By Eliza Slawther

The UK MHRA has emphasized the merits of the Project Orbis scheme, which has resulted in 12 new drug approvals and 14 indication extensions in the country so far. However, overall annual approval figures were lower in 2023 and 2024 than in the years prior.

‘We Need To Move With The Times’: Cell & Gene Therapy Catapult CEO On UK’s Regulatory Overhaul

 
• By Eliza Slawther

The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.

Prasad’s Return Shelves Center Consolidation, But Maybe An Opening For OCE 2.0?

 
• By Kate Rawson

Vinay Prasad’s exit from the US FDA reignited conversations about integrating its drugs and biologics centers under George Tidmarsh. Those plans appear to be shelved, but the leadership transition could be an opportunity to fully realize the vision for the Oncology Center of Excellence.

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.