Tag Archives: FDA

AdComm Drop-off in 2019 – FDA Consults Fewer Experts in 2019

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

Posted in Uncategorized | Tagged , , , | Leave a comment

FDA OPDP Research – A Foggy Window into Future Thinking on Digital Media

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

Posted in New and Social Media | Tagged , , | Comments Off on FDA OPDP Research – A Foggy Window into Future Thinking on Digital Media

Enforcement Updates: OPDP Issues First Letter of the Year

In recent years, FDA’s Office of Prescription Drug Promotion (OPDP) has been diminished in the volume of its enforcement expressed through the issuance of Warning and Untitled Letters. OPDP now sends out only a handful of letters each year when … Continue reading

Posted in Warning Letters | Tagged , , | 2 Comments

Gottlieb Set a New Bar – What Happens Now?

The news that Dr. Gottlieb was leaving his post as Commissioner of FDA took everyone by surprise. Perhaps another surprise to many was the skill and judgment he brought to the job when initially he faced many critics due to … Continue reading

Posted in Current Affairs, FDA Image | Tagged , , | Comments Off on Gottlieb Set a New Bar – What Happens Now?

FDA’s Contribution to the Pricing Issue – Generic Activism

As hearings on Capitol Hill these past two months (and in the months to come) have examined the issue of pharmaceutical pricing to inform potential legislation as well as to garner attention, FDA has been addressing the issue in the … Continue reading

Posted in Generic Drugs | Tagged , , | Comments Off on FDA’s Contribution to the Pricing Issue – Generic Activism