Last month, FDA issued two final guidances on medical product communications, including communications by medical device companies about unapproved uses of approved/cleared medical products: “Medical Product Communications That Are With the FDA-Required Labeling—Questions and Answers” (CWL Guidance) and “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers” (Payor Guidance). Taken together, … Continue Reading