FDA Draft guidelines: Real world examples

screenshot_1393By now M-L-R teams are reading the draft guidelines from the FDA for Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics.  The most debated content of this document is going to be ” A firm is responsible for product promotional communications on sites that are owned, controlled, created, influenced, or operated by, or on behalf of, the firm .Continue reading

FDA warning letters continue decline

Either pharma marketers are finally getting it or the FDA does’t have the staff to review DTC advertising but NOV’s and Warning letters are down.  My guess is that the decline in DTC advertising along with cut in DTP marketing are huge factors along with a strategic move to move most marketing to digital.  The FDA is still trying to figure out digital and is taking on a research project to waste money when all they really need to do is read some of the data from Manhattan Research. Continue reading