Author Archives: Mark Senak

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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Weekly Roundup 5.25.18

It is Memorial Day Weekend!  The opening bell for summer vacations has arrived. It is time to do your wardrobe switch – get out the white shoes, sandals and linen clothing and put the corduroys away until Labor Day. Time … Continue reading

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Weekly Roundup 5.18.18

There has been so much rain in the past week, it is difficult for those of us in Washington, D.C. to remember that we live in that Washington and not Washington state. It has been relentless and it continues. It … Continue reading

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