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Industry groups petition the FDA over off-label rule

Mar 20, 2017 - Medical Marketing & Media (MMM)

UPDATE: The FDA announced March 17 that it would delay the rule until March 19, 2018.

Industry groups are taking aim at a rule created by the Food and Drug Administration that could restrict drugmakers' truthful and non-misleading promotion of its drugs - commonly referred to as off-label promotion - by expanding the evidence the agency can use to assert that a drug has been misbranded.

The FDA filed the final rule in the Federal Register on January 9. A citizen petition was filed by...