FDA Breaks Medical Product Communications Silence

By attorneys with Lowenstein Sandler LLP (January 27, 2017, 12:42 PM EST) -- James C. Shehan

Tara P. D'Orsi

Donna E. Hanrahan By releasing two draft guidances on medical product communications on Jan. 18, the U.S. Food and Drug Administration has broken its long silence on medical product communications. The timing of the release in the waning days of the Obama administration appears to be an effort by the FDA to get its position on the record in an attempt to avoid being trumped by the incoming administration; that effort may be thwarted by the current administration's move to roll back recently issued regulations.

One draft guidance addresses drug and device manufacturer communications with...

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