Author Archives: Mark Senak

OPDP Sends Third Enforcement Letter of the Year

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

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OPDP Takes Second Enforcement Action of the Year

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

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A Look at the FDA Revamped the Website

It has been a long time since FDA did much to its website. Being such a large and diverse agency, managing the site cannot be an easy thing. Aesthetics apart, just keeping track of pathways and names can be overwhelming … Continue reading

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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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