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.
Drug wholesaler Amerisourcebergen agreed in federal court to pay $260 million and plead guilty to violating federal drug law via a criminal scheme to sell cancer drugs illegally repackaged in pre-filled syringes. Read More
The FDA launched a new search dashboard for its adverse event reporting database, promising a more user-friendly method for industry and the general public to access the agency’s safety and surveillance data. Read More
Manufacturers of short-acting opioids will be required to offer the kind of doctor training in administering the medications that their extended-release counterparts have been directed to provide since 2012, FDA Commissioner Scott Gottlieb said. Read More
The FDA has failed to properly address safety issues relating to an over-the-counter teething medication and should act within 30 days to remedy the situation, a lawsuit by Public Citizen said. Read More
The FDA has largely succeeded in expediting the review of drugs with larger health gains, but postmarket trials by companies have fallen behind in confirming some of those benefits, with many not using the gold standard of randomized controlled trials, according to two independent studies. Read More
The FDA directed a Canadian opioid manufacturer to send information to doctors correcting the complete absence of warnings of serious risks associated with the drug in professional promotional materials distributed earlier. Read More