FDLI Off-Label Promotion Discussion Ventures Into “Abstract” Territory
This article was originally published in The Gray Sheet
Executive Summary
Companies should request records of FDA correspondence related to premarket notification when weighing the purchase of another firm's 510(k), attorney Jeffrey Gibbs advised during a Sept. 13-14 Food & Drug Law Institute meeting in Washington, D.C
You may also be interested in...
FDA Denies WLF Petition To Allow Dissemination Of Off-Label Information
Dissemination of journal reprints representing off-label use of a device or drug will not by themselves trigger FDA enforcement action against a manufacturer, according to the agency
Stay Or Exit? Global Health Players Ponder New China Trajectory
It's again the time of year when global CEOs descend on China's capital to discuss strategies. This year, however, the mood is different.
Report Finds Digital Diabetes Tools Deliver No ‘Meaningful Clinical Benefits'
A new report from health economics group the Peterson Health Technology Institute found that apps to help patients manage their blood sugar levels delivered few of the promised benefits. However, a digital therapeutics industry association says PHTI’s research cast too narrow a net.