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Free Speech Off-Label Promotion Draft Guidance

Jones Day

The Continuing Story of Manufacturers' Off-Label Promotion of Approved or Cleared Medical Products

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Prior to the end of the previous Administration, FDA released several draft guidance documents and a white paper addressing different types of communications about medical products. On January 18, 2017, FDA published two...more

Skadden, Arps, Slate, Meagher & Flom LLP

"FDA Publications Double Down on Agency’s Ability to Prohibit Off-Label Communications, but Narrow Scope of Debate"

On the eve of a change in administration, the U.S. Food and Drug Administration (FDA or the Agency) released a flurry of documents regarding off-label communications and FDA’s ability to regulate such communications within...more

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