Hilde Boone, Pharm, MSc, is the European Medicines Agency’s liaison official at the U.S. FDA. Boone’s post was established this past winter (FDA, reciprocating, also has a representative in London who liaises with EMA). Boone embodies a new era of collaboration between American and European regulators, and among global authorities.
GW Pharmaceutical has announced that its U.K. manufacturing facility has received regulatory approval, in advance of its launch of cannabis-based Sativex into the European market. A blast from the past: We caught up with GW a few years ago to discuss the process by which cannabis plants are turned into...
“We are seeing an increasing frequency of inspections from FDA and the rest of the world,” says John O'Connor, PhD, senior director of Corporate Inspection Management for Genentech. “The question is, what’s the value of a duplicate inspection? We don’t believe it adds value to the product.
John Graham of the conservative California think tank, the Pacific Research Institute, just published a research report, Leviathan's Drug Problem, arguing that FDA is overstaffed, overfunded and unproductive. He traces patient wait times for new medicines as contributing to far more loss of life than food contamination.
At a session on Wednesday afternoon, Richard Friedman of CDER discussed FDA and foreign inspections of manufacturing sites, and mentioned proposed solutions that would harmonize requirements and lighten the load, while maintaining standards. They include a global system of surveillance and mutual inspectorate acceptance.