1. Pink Sheet
  2. >>Regulatory Trackers

US FDA Oncology AdComm's Pediatric Study Reviews Go Virtual

 
• By Sue Sutter

ODAC's 17-18 June discussion of pediatric development plans for four investigational oncology agents will serve as a trial run of the technology platform and logistics for any future application-specific virtual advisory committee meeting, but without the stress associated with a pending application and a user fee deadline.

Young woman's feet dipping slowly in the water.
US FDA's drugs center is dipping its toes in the virtual AdComm waters. • Source: Shutterstock

The COVID-19 outbreak has led the US FDA’s Center for Drug Evaluation and Research to dip its toes into the virtual advisory committee waters with a two-day panel review of pediatric development plans for four oncologic agents.

On 17-18 June, the Oncologic Drugs Advisory Committee’s pediatric oncology subcommittee will convene online to discuss issues related to the drugs’ development for pediatric use and to provide guidance to

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 US FDA Performance Tracker

More from Regulatory Trackers

AMR-Targeting Drug Secures EMA PRIME Designation

 
• By Neena Brizmohun

Antabio’s next-generation, broad-spectrum antibacterial, MEM-ANT3310, has made it onto the European Medicines Agency’s priority medicines scheme. The company says its product is designed to make a significant impact on the growing problem of antimicrobial resistance.

Global Pharma Guidance Tracker - March 2025

 
• By Vibha Sharma and Anabel Costa-Ferreira

Stay up to date on regulatory guidelines from around the world with the Pink Sheet’s Guidance Tracker. The complete Global Pharma Guidance Tracker, with sortable and searchable listings going back to 2014, is available online.

US FDA’s Review Performance Held Steady Despite Stormy First Quarter

 
• By Bridget Silverman

Organizational turmoil has not yet affected reviews of novel agent applications, with Q1 2025 approvals coming in low, but the first quarter share of the entire year is variable.