1. Pink Sheet

US FDA Eager To INTERACT With Start-Ups, Not Check Boxes

 
• By Michael McCaughan

A US FDA webinar for start-up sponsors showcased staff who sound enthusiastic about helping drug developers advance their projects, while also emphasizing the importance of early and continual engagement with the agency.

meeting
The FDA wants start-ups to take advantage of all meeting opportunities. • Source: Shutterstock

The new INTERACT meeting process can be a critical step for start-up sponsors to avoid early stumbles in their attempts to move into human trials, US Food and Drug Administration officials emphasized during a recent webinar offering “Regulatory Do’s and Don’ts” for small businesses.

Key Takeaways

  • FDA officials want start-up sponsors to take advantage of opportunities to meet with the agency.

  • The agency said INTERACT meetings are not...

“I highly recommend you take advantage of the meeting opportunities” outlined during the webinar, Center for Biologics Evaluation and Research CMC Reviewer Karin Knudson said. “In particular for early-phase studies,...

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