October 13, 2011
Last week it was noted that enforcement at DDMAC, newly renamed the Office of Prescription Drug Promotion (OPDP) has slowed down. Last quarter, the division, now an office, issued only four letters. Not only is it worthwhile to look at … Continue reading →
October 4, 2011
For some time there has been speculation that enforcement at FDA is up. But it should be noted that regulatory action letters come from several different parts of the agency and encompass much more than promotional communications. For our purposes, … Continue reading →
September 7, 2011
Remember when the calendar was turning to the year 2000 and there was a great hand-wringing going on about whether or not Y2K would bring a digital meltdown? And then the clock ticked, and it didn’t? One was reminded of … Continue reading →
August 11, 2011
Earlier this week, we examined the Warning and NOV letters that came from FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC). Today we’re going to look at a few of the communications lessons learned from same – and reminding … Continue reading →
April 13, 2011
For a while it seemed that FDA’s DDMAC was raising the enforcement bar. During the Bush years, enforcement plummeted from previous years dramatically. In 2008, the numbers seemed to rise, though in 2009, the numbers were actually a bit thrown … Continue reading →