US ? Dealing with off-label use comments on social media - FDA issues guidance

摘要

The US Food and Drug Administration has issued much-awaited guidance on how manufacturers and distributors of prescription drugs and medical devices should respond to unsolicited requests for information on the off-label uses of their products.The guidance also covers requests for information that firms may encounter through emerging electronic media.The guideline is currently in draft form and stakeholders have until 29 March to submit feedback.The document only deals with unsolicited requests (ie initiated by persons or entities that are completely independent of the relevant firm) and contains examples to illustrate that these are different from solicited requests (ie prompted in any way by a manufacturer or its representatives).