FDA Early Collaboration Guidance Offers Incentives For Formal Meetings
This article was originally published in The Gray Sheet
Executive Summary
Device manufacturers have the option of postponing agreement meetings until informal "pre-meetings" with FDA are completed, according to a revised guidance outlining early collaborations under the FDA Modernization Act of 1997.
You may also be interested in...
120-Day Expedited Reviews: “Up-Front” Planning Is Key, FDA/Industry Says
Coordination of advisory panel meetings will be key to implementing 120-day expedited reviews for breakthrough devices, FDA and AdvaMed agree
120-Day Expedited Reviews: “Up-Front” Planning Is Key, FDA/Industry Says
Coordination of advisory panel meetings will be key to implementing 120-day expedited reviews for breakthrough devices, FDA and AdvaMed agree
CDRH Ombudsman Resolves Industry Complaints, Launches QA Survey
Over 80 percent of the complaints and disputes lodged with the Center for Devices and Radiological Health over the past year have been decided in industry's favor, suggesting a favorable outlook for the 13 currently pending in the center's ombudsman office.