I am a regulatory affairs consultant specializing in compliance with FDA’s regulation of prescription drug promotion — i.e., the requirements of FDA's Office of Prescription Drug Promotion (OPDP), formerly DDMAC.

In 2013 I wrote FDA Requirements for Prescription Drug Promotion, the first comprehensive book on the topic, published by the Regulatory Affairs Professionals Society (RAPS).

I maintain a set of news and resources relating to FDA & its regulation of prescription drug promotion at www.OPDPresources.com.