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.
Synthetic opioids have overtaken prescription opioids as the leading cause of overdose deaths in the U.S., according to a report published by the Journal of the American Medical Association, which studied 2010-2016 mortality data. Read More
The European Medicines Agency’s Pharmacovigilance Risk Assessment Committee is requesting that sponsors of antiretrovirals submit, by May 8, supplementary safety information related to the risk of autoimmune hepatitis. Read More