This week FDA sent a Warning Letter to a company engaged in marketing products containing cannabidiol (CBD) to consumers for a wide variety of uses in both humans and canines. In addition to the letter, the agency underscored their action … Continue reading
During the past few years, there has been a renewed focus on facilitating the development of new medicines by providing new mechanisms to streamline the review process and get drugs to patients more quickly. The passage of the 21st Century … Continue reading
The folks at the Office of Prescription Drug Promotion (OPDP) have been in the mood lately to make a point. You can tell because they recently issued the third regulatory action letter of the year. Many years ago this would … Continue reading
This week FDA’s Office of Prescription Drug Promotion (OPDP) posted what was only the second enforcement letter of the year which was issued in May. Warning letters are issued by many parts of the FDA, but OPDP issues letters squarely … Continue reading
Over the past few years, regulatory action letters from FDA’s Office of Prescription Drug Promotion (OPDP), while once plentiful, has been something of a rare occurrence. In response to questions on the matter, FDA was often vague. This week however, … Continue reading
