The FDA, the European Medicines Agency and Japan's Pharmaceuticals and Medical Devices Agency recently met to align clinical study designs for antibacterial drugs so that a single development program could meet the requirements for all three regulators. The agencies also discussed alignment on antifungal development, anti-infective drugs for children, differences in susceptibility testing and trial considerations for new types of therapies.
FDA, EMA, PMDA to align clinical trial designs for antibacterial drugs
Sign up for AIChE SmartBrief
News for chemical engineers
Get the intelligence you need: news and information that is changing your industry today, hand-curated by our professional editors from thousands of sources and delivered straight to your inbox.