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.
Use of the “multiple comparison procedure – modeling,” or MCP-Mod, approach to dose response testing and estimation provides a “more solid basis” for Phase III dose selection, the European Medicines Agency says in a recently posted draft opinion on the methodology. Read More
While the FDA generally requires two Phase III trials to support approval of drugs to treat acute bacterial skin and skin structure infections (ABSSSI), an Oct. 16 final guidance says a single Phase III study that is supported by additional independent evidence may suffice. Read More