Author Archives: Mark Senak

Weekly Roundup 7.13.18

Happy Friday the 13th, one of two for this year. Don’t worry, the other one happened already in April. I have been out on vacay for a bit, along with many I think. But back at the grind now and … Continue reading

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Weekly Roundup 6.29.18

Apologies are in order for the interruption in the Weekly Roundup schedule and no postings the last few Fridays. It was partially inspired by the fact that it was a busy  few weeks for me.  Conversely it seemed not so … Continue reading

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A (Slight) Liberalization of Communications with Docs from FDA

What Happened. This week FDA issued a new final guidance related to communications about medical products that, while representing a slight liberalization of regulation when it comes to discussing useful information about a drug and the cleared uses for it, … Continue reading

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The Back and Forth on Safety Versus Speed and FDA

This week the Commissioner issued a statement related to the proposed modernization of the FDA’s drug review office, also the subject of a blog post by FDA’s head of the Center for Drug Evaluation and Research Janet Woodcock. While focused … Continue reading

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Weekly Roundup 6.1.18

While not the official one, the summer I knew as a kid – the one beginning after Memorial Day – has arrived. Officially I guess we have to wait a few more weeks. Once again a week without an intervening … Continue reading

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