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.
An FDA advisory panel voted down Zogenix’s Zohydro ER due to concerns on its potential for abuse and addiction. In a 2–11 vote with one abstention, the panel on Dec. 7 voted against recommending approval for hydrocodone bitrate extended-release capsules, which would be classified as a Schedule II with “high potential for abuse.” If approved, the tablets would be the first single-entity hydrocodone analgesic. Washington Drug Letter