OPDP Enforcement Actions: How to Be Prepared for the Year Ahead
Presented by Joy Liu
Recorded On: Thursday, January 24, 2013
For the marketing, legal, and regulatory personnel of pharmaceutical companies, complying with FDA regulations and guidance concerning drug advertising and promotion can be a complex task fraught with significant risks. You must have a thorough understanding of how the FDA interprets and applies advertising and promotion regulations – and put your knowledge to action – to avoid enforcement actions such as Warning Letters and Untitled Letters.
Joy Liu represents large pharmaceutical, biotechnology, and medical device companies on a broad range of FDA regulatory issues. Joy has developed a particular expertise in counseling companies on advertising and promotion issues, and has, in that respect, served as the legal reviewer on promotional review committees for both large and small pharmaceutical companies and helped to advise the Medical Information Working Group, a coalition of more than a dozen pharmaceutical and device manufacturers interested in seeking clarity in government policies governing promotional practices.