Category: Off-label Promotion

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Bad Ad Program Yields Two OPDP Enforcement Letters on Risk, Safety Information

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House Bill on Sharing Certain Information about Investigational Products Moves Forward

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House Subcommittee Considers Two Off-label Bills

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Response to Califf’s Call for Off-label Code of Ethics Is on Industry’s Radar

Califf Calls for Off-label Promotion Code of Ethics

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Citizen Petition Calls on FDA to Stay Final Rule Establishing “Totality of the Evidence” Standard for Intended Use

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New Memorandum Spells Out FDA’s First Amendment Position on Off-label Use Promotion

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FDA Extending Unapproved Use Communications Comment Period

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Speakers at FDA Off-label Hearing Call for Action that Protects Free Speech