The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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 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
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