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 FDA is working with APP Pharmaceuticals and Hospira, the two remaining U.S. suppliers of propofol, to ensure adequate supplies of the injectable anesthetic now that Teva Parenteral Medicines has stopped manufacturing it. APP has been covering most of the market, and the agency is working with the company to increase supplies, FDA spokeswoman Crystal Rice said. Hospira, which is not currently distributing the product, is trying to return to the market as quickly as possible, she added. Propofol is difficult to manufacture and has little to no profitability, Teva spokeswoman Denise Bradley said. Generic Line