The U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb recently announced that the agency plans to publish a draft guidance outlining a voluntary alternative pathway for new, moderate-risk devices for use in...more
FDA recently issued a draft guidance, “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities—Questions and Answers”, which is intended to bring clarity to a specific provision in...more
On January 18, the Food and Drug Administration (FDA or the Agency) issued a draft guidance, Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities – Questions and Answers. This...more