FDA Enforcement Updates: OPDP Targets Promotional Material Webinar

For a little over a year, the Office of Prescription Drug Promotion (OPDP) sent no untitled letters. OPDP ended this untitled letter hiatus this summer when it sent two untitled letters—one in June and another in August—and a warning letter in August, reminding everyone that an untitled letter may still appear on your doorstep if you do not follow promotional regulations. All letters stemmed from false or misleading presentation of risk and benefit information—showing OPDP is still here and is scouring through claims, even down to the datapoints.

This webinar covers the following topics:

• Background on OPDP untitled and warning letters
• How the FDA monitors medical product promotions
• Untitled letter examples; and
• How companies can remain compliant

Click here to download the presentation slides.