Author Archives: Mark Senak

Weekly Roundup 4.13.18

For those of superstition, it is the first of two Friday the 13ths for this year. For the rest of us, we are assessing our bad luck with regard to the fact that if you live in the mid-Atlantic it … Continue reading

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FDA Enforcement Lags, Focus on Promotion of Unapproved Drugs

It goes without saying that enforcement by FDA’s Office of Prescription Drug Promotion (OPDP) as identified through regulatory action letters (warning or untitled) over the past few years is a mere shadow of its former self. Enforcement was once robust, … Continue reading

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Weekly Roundup 4.6.18

This has been a rather extraordinary year from an FDA perspective. Last year there were record approvals and a number of firsts. Advances in oncology have been eye opening to say the least. And on a policy front, there has … Continue reading

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What They Said – FDA Press Releases 1st Quarter 2018

FDA has had a lot to say so far this year. A real lot. In fact, during the first three months of 2018, FDA issued 56 press releases, which is as many as they issued during the entire first half … Continue reading

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Weekly Roundup 3.30.18

It is hard to believe, but we have completed the first quarter of 2018. Time is flying. Spring is springing. And we are the cusp of the commencement of another election cycle.  It has been another busy week without a … Continue reading

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