January 20, 2011
FDA’s Division for Drug Marketing, Advertising and Communications (DDMAC) is responsible for regulating the communications by medical product manufacturers with the public about their products. During 2010, the agency issued 52 letters, which is more than during any year since … Continue reading →
January 11, 2011
Warning letters and NOV letters from DDMAC have a rather irregular cycle of posting to the FDA/DDMAC Web site. Some of the letters are posted the very day they are sent, others are not posted for days, sometimes weeks afterwards. … Continue reading →
August 12, 2010
Everyone has noticed the uptick in Warning Letters and NOV letters coming out of DDMAC these days and written about several times over the past year on this blog. In case you haven't, here is an updated chart where I … Continue reading →
July 7, 2010
Looking at things from a strictly quantitative point of view, for sometime now, there has been speculation that the FDA was ramping up enforcement when it came to medical product promotion. That was first seen in 2009 when there was … Continue reading →
May 12, 2010
"Paging Dr. Draper! Paging Dr. Draper! We have an ad in the examination room that requires your attention, STAT!" The PA system goes quiet. In the waiting room, patients shuffle their feet nervously, waiting, waiting, waiting…. Dr. Draper enters the … Continue reading →