The system of FDA Advisory Committees is in place so that when FDA needs advice – either on policy development, reviewing an issue with an already approved medicine, or regarding new drug approvals – the agency has a lot of … Continue reading
Last week FDA and FTC jointly issued a warning letter to a seller of CBD products in Florida – the seventh such warning letter of the year. The letter took issue with the manufactuer’s marketing practices related to multiple products … Continue reading
Last year new molecular entities (NMEs) were approved by FDA at a record clip, surpassing the prior record of 45 that was set in 2015. As we begin the final quarter of hte year, this is a good time to … Continue reading
For those who like to keep up on the activity of the Office of Prescription Drug Promotion (OPDP) here is an update. While not shaping up to be another big year of enforcement, there has been a bit of activity … Continue reading
When one thinks of FDA’s Office of Prescription Drug Promotion (OPDP) there is a likely tendency to think of the regulatory action letters – Warning Letters or Untitled Letters -issued by that office to pharmaceutical companies about their promotional communications. … Continue reading
