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.
Generic preemption issues may again wind up before the Supreme Court as generic maker Mutual Pharmaceutical is calling on it to reverse an appeals court decision that upheld a $21 million jury award to a patient injured by Mutual’s sulindac. Mutual argues the First Circuit Court of Appeals ignored Supreme Court precedent and the decisions laid down by all of its sister courts. Washington Drug Letter