Monthly Archives: June 2018

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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