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.
Surviving the New FDA Inspection Plan: A Drugmaker’s Guide to Working with the Agency explains the agency’s integrated approach and how you can make the most of the FDA’s quality priorities and inspection procedures.
This new edition of The 21st Century Take on Observational Studies presents new information on the encouraging results those pioneers have found. New to this edition are the results of a groundbreaking study from Tufts University’s Center for the Study of Drug Development.