1. Pink Sheet
  2. >>Pathways & Standards

Real-Time Oncology Review Has Sponsors Rethinking What Data To Share With US FDA And When

 
• By Sue Sutter

Pilot program that gives agency early look at pivotal data has forced sponsors to change how they go about preparing supplemental applications; potential expansion to new molecular entities would bring new challenges, including need to align manufacturing and clinical site inspections with expedited review timeline.

a stylish mechanical watch on the arm of a man dressed in a blue jacket with a white shirt that watches the time on the clock holding the clock by hand

The US FDA’s Real-Time Oncology Review (RTOR) pilot program has required participating sponsors to change how they prepare and submit supplemental applications, but these challenges have come with some big payoffs, including greater certainty about application acceptance and review times that can be counted in days and weeks, as opposed to months.

While RTOR currently is being piloted for only the most straightforward supplemental applications, future expansion to more complex supplements or to new molecular entities (NME) could bring a host of...

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

US FDA Adcomm To Consider If Genentech’s Columvi Study Generalizable To US

 
• By Sue Sutter

Patients from Asia saw a differential treatment effect versus non-Asian regions in the Phase III multiregional study, with an adverse survival trend seen in the latter group, the FDA said about the lymphoma drug.

Califf In Conversation: ‘Decimated’ US FDA Teams Endanger Innovation

 
• By Barnaby Pickering

Pink Sheet sister publication In Vivo spoke to the former FDA commissioner about the recent layoffs and their impact on vaccine and other product development.

New EU Filings

 
• By Neena Brizmohun

Brensocatib, Insmed's investigational treatment for non-cystic fibrosis bronchiectasis, is among the latest products that have been filed for review by the European Medicines Agency for potential EU marketing approval.

UK’s International Recognition Procedure: EU Dossier Faster Than US Or Canada

 
• By Eliza Slawther

Companies that use the European Medicines Agency as a reference regulator for the UK’s International Recognition Procedure can expect a faster approval than those that use other national regulators, such as those in the US and Canada, an MHRA spokesperson has said.

More from Pathways & Standards