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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
ClinicalTrials.gov received a new set of usability updates last month, including additional local search functions, a new glossary feature and redesigned study record pages. Read More
FDA released two guidance documents focusing on communications between the agency and drug developers to make drug development more efficient and to help sponsors avoid costly delays. Read More
Spending on prescription drugs sold through retail pharmacies in 2015 were estimated to comprise nearly 12 percent of total personal health care services spending in the United States. Read More