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 has handed Luitpold Pharmaceuticals a Complete Response Letter (CRL) on its NDA for Injectafer after a recent inspection raised concerns about the drugmaker’s Shirley, N.Y., manufacturing facility. Luitpold, which plans to produce Injectafer (ferric carboxymaltose injection) for the U.S. market at the Long Island plant, stressed that the CRL did not include any concerns about its NDA submission. Drug GMP Report