US FDA Oncology Team Says Sponsor Meetings Are Still Mostly Virtual, And That’s OK

The US FDA’s cancer drug review managers say most sponsors are happy to continue with virtual meetings, even though in-person opportunities are offered. Managers also see advantages to the virtual format for staff development.

virtual meeting
Most oncology sponsors continue to request virtual meetings, FDA officials said. • Source: Shutterstock

The US Food and Drug Administration’s oncology review managers are seeing relatively few requests for in-person meetings with sponsors and seem very comfortable with relying on virtual sessions moving forward.

Key Takeaways
  • Most sponsors still want to conduct virtual meetings with the FDA, oncology office officials said.

  • In-person meetings are a very different experience for new staff because they are rare

“We do have some requests” for in-person meetings, “but it is not an overwhelming amount,” Division of Hematologic Malignancies II Director Nicole Gormley said during a 9 May FDA-American Association of Cancer Research workshop on trial designs for perioperative oncology regimens

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

More from Product Reviews

Keep Talking: US FDA’s Beleagured Biologics Center Remains Vital To Regenerative Medicine

 

Advisory committee for Capricor’s deriamocel planned, regenerative medicine advanced therapy designations proliferate for osteoarthritis, and the ranks of dual RMAT/breakthrough therapy designation holders grow.

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

US FDA Advisory Committee Misperceptions Abound … At HHS

 

HHS Secretary Robert F. Kennedy Jr. regularly decries the “conflicts of interest” he believes abound in advisory committees, but his concerns, as well as a recent “policy directive” eliminating industry representatives, seem driven by a misunderstanding of the panels’ jobs.

US FDA Layoffs Hit Conflict-Of-Interest Screening For ODAC Meeting

 

Screening for conflicts and finding the right expertise for a two-day Oncologic Drugs Advisory Committee meeting on four products has been complicated by the Trump Administration’s initial communications freeze and subsequent layoffs in CDER.

More from Pink Sheet

Recent and Upcoming FDA Advisory Committee Meetings

 
• By 

Recent and upcoming US FDA advisory committee meetings and a summary of the topics covered.

UK Health Data Research Service Looks ‘Encouraging’ For Industry, But Implementation Details Will Be Key

 

Marcus Vass and Vladimir Murovec of international law firm Osborne Clarke tell the Pink Sheet what the government's planned HDRS might mean for industry, and how it compares with the European Health Data Space.

EU Health Data Space May Speed Up R&D Through Access To Multi-Omics & Clinical Record Data

 

The European Health Data Space framework will allow companies to accelerate R&D processes and identify new molecular targets faster by facilitating centralized access to certain types of high-quality data, Finland’s Orion Pharma says.