Off-Label Use Discussions Should Stay Off-line, FDA Draft Guidance Says
FDA advises companies to respond to unsolicited requests for off-label information in one-on-one dialogue; the agency also requests public comments on its policies regarding off-label communications in response to an industry citizen petition.
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Rx Drug Promotion Studies Target Biosimilar Disclosures, Unapproved Uses, Multiple Indications
US FDA proposes studies to look at the impact of disclosure of a product’s secondary claims and biosimilar designation; disclosure about unapproved uses; and the impact of citing a drug’s multiple indications in TV ads.
Website “Influence” Shouldn’t Make Firms Responsible For Content – PhRMA
FDA’s social media guidance on interactive promotional materials should require companies to submit only content that they have control over, PhRMA and BIO tell FDA; industry asks for clarification on a firm’s responsibility for user-generated content, such as comments on off-label use.
FDA Reprint Policy Expands To Clinical Practice Guidelines, Medical Reference Texts
FDA has revised, but not loosened, its 2009 final guidance on good reprint practices for distribution of journal articles on unapproved uses of approved drugs and devices.