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DoD’s Office of Health Affairs and the FDA will collaborate in reviewing products meant to treat, prevent or diagnose serious or life-threatening conditions for troops. Read More
The European Medicines Agency adopted the International Council for Harmonization E7 guideline on multi-region clinical trials, which can support simultaneous product submissions in different parts of the world and more efficient drug development. Read More
Enabling access to medical countermeasures for material threats is a top FDA priority, according to Commissioner Scott Gottlieb, who reviewed the agency’s efforts before a Senate committee Wednesday. Read More
The federal government pushed back its revisions to the Common Rule for an additional six months — making the announcement less than 36 hours before the changes were set to take effect Jan. 19 — and warned the public to expect additional delays down the line. Read More
The FDA and the Department of Defense announced a joint program Tuesday to prioritize development of medical products for deployed military personnel. Read More
The new guidance distinguishes between trials involving DMARD-naïve patients, those who have had an inadequate response to one prior DMARD treatment and those who have had an inadequate response to multiple treatments. Read More
The European Medicines Agency updated guidance on clinical investigations of rheumatoid arthritis drugs to add new endpoints and distinguish between patient subgroups in trials. Read More
Massive amounts of clinical trial data are lengthening drug development timelines as technical challenges create costly bottlenecks, according to a new industry survey from the Tufts Center for the Study of Drug Development. Read More