FDA Promises Guidance on Premarket Communication With Sponsors

The FDA says it will publish a guidance for review staff and industry describing best practices for interactive communication with sponsors during drug development and create a new liaison position to facilitate the extra premarket communication. The proposal is part of a package the agency has negotiated with the biopharma industry for the reauthorization of the Prescription Drug User Fee Act, PDUFA V, which would begin in fiscal 2013. Final terms of those negotiations were ratified by the agency and industry representatives May 31.
Clinical Trials Advisor