June 14, 2018 – Although they may not be perfect, the two final guidance documents issued this week by the FDA do provide more information and examples to help pharma companies navigate how they communicate with payors and how they ensure that their on-label communications are compliant. In a June 12 statement, FDA Commissioner Scott […]
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Jan. 27, 2017 – The FDA issued draft guidance last week that is designed to help medical product manufacturers understand how the agency evaluates product communications, including promotional materials, that present information not contained in the FDA-required labeling but that may be “consistent with” that labeling. “We are aware that firms have questions about how […]
Read moreApril 25, 2016 — In a speech at the Alliance for a Stronger FDA’s quarterly meeting April 19, new Commissioner of Food and Drugs Dr. Robert M. Califf stated that the agency’s current priorities include determining when advertising is false or misleading and addressing labeling and patient/consumer communication, among others. He also indicated that the […]
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