Tag Archives: FDA

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

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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

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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

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Sorting it Out – FDA AdComm Review for 2018

In 2017, the Advisory Committees voted to recommend approval 71.4 percent of the time; in 2018 it was 66.6 percent. Continue reading

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Happy New Year – and FDA Statement on Government Shutdown

Happy New Year. On a personal note, I have been on a hiatus or shutdown myself to take time while undertaking a move. With that behind me, I am back at it and will be posting again with intermittent content … Continue reading

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