Author Archives: Mark Senak

What They Said – FDA Press Releases First Half 2019 – B.G and A.G (Before Gottlieb/After Gottlieb)

One of the many things notable during the tenure of Dr. Scott Gottlieb as FDA Commissioner was the change in communications – a change marked not just by style but substance. In fact, in a March posting here, it was … Continue reading

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New Drug Approvals – A Mid-Year Assessment

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

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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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