FDA News

FDA Makes Critical Data Update to the Orange Book

On Wednesday, January 25th, the FDA unveiled a critical data update to Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the “Orange Book.”  According to the Agency’s announcement, “search results and drug listings now clarify which listed... Read More

Medical Product Communication, Part One: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers

On January 18, 2017, the FDA released two draft guidance documents regarding communications concerning medical products.  The first draft guidance, entitled “Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities – Questions and Answers,” contains a number... Read More