INTERACT Meeting Timing Remains Point Of Confusion

US FDA review divisions will determine whether the meeting is appropriate because there are no one-size-fits-all requirements.

ambiguity
The development timing for an INTERACT meeting remains a regulatory gray area. • Source: Shutterstock

Sponsors may have been excited to expand the US Food and Drug Administration’s INTERACT meeting program, but many are finding it difficult to access, in part because the acceptance requirements remain a regulatory gray area.

Key Takeaways
  • Sponsors want more clarity on the ideal time in development to conduct an INTERACT meeting.

The Initial Targeted Engagement for Regulatory Advice on CBER/CDER ProducTs (INTERACT) meeting is designed to help sponsors early in drug...

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 Review Pathways

Expedited Reviews For China-Originated Drugs Shift Back Home

 
• By 

The proportion of China-originated drugs granted expedited reviews in China doubled in the first half of this year, Pharmaprojects data show, surpassing those receiving similar treatment in the US and likely driven by multiple factors.

Sarepta Will Resume US Elevidys Shipments For Ambulatory DMD Patients After FDA Reverses Course

 
• By 

The FDA recommended removal of a voluntary hold on shipments of the gene therapy to younger patients after finding that the death of an 8-year-old boy in Brazil was unrelated to Elevidys. Discussions on safety of DMD treatment for non-ambulatory patients is ongoing.

US FDA Commissioner Makary Is Learning To Appreciate His Staff

 

After three months on the job, FDA Commissioner Martin Makary is sounding much more effusive about the quality of the agency staff. Better late than never?

‘Unprecedented Story’: Revoked EU Marketing Authorization Fails To Thwart Translarna Sales

 

PTC Therapeutics is continuing to supply its Duchenne muscular dystrophy treatment, Translarna, in some European markets, despite EU revocation of the drug’s conditional marketing authorization earlier this year.

More from Conferences

PDUFA VIII: Cutting Perceived Conflict Of Interest May Be A Theme

 

Ongoing questions about user fees exerting too much influence over the FDA could spawn a shift in the PDUFA structure when talks begin later this year.

Post-BIO Podcast: Thoughts From The Frontlines

Pink Sheet and Scrip journalists reflect on the mood from Boston, the most important takeaways and what’s next for industry.

BIO CEO On Industry And US FDA, Trump’s Vaccine Views And MFN Counter Proposals

 

John Crowley discussed how he prioritizes industry’s many competing challenges in a Pink Sheet interview at the BIO International Convention.