Daily Archives: April 13, 2016


Case 7 “Ingredient Performance”: Navigating Regulatory Expectations: Lessons Learned for Advertising and Promotion

Now the seventh area is ingredient performance. The brand example here is a PICC line or a peripherally inserted central catheter that was in development by a major medical device company. This central catheter was made from a novel plastic compound as well as an anticoagulant coating that actually prevented clots in the patient. They had some very dramatic photographs showing side-by-side results of other catheters and the clots that actually formed around them versus this catheter that was made of the novel plastic and coating that did not have any of the blood clots. However, when it came time […]