FDA Internet Draft Guidance: Firms Responsible For Promotions On Third-Party Sites
This article was originally published in The Pink Sheet Daily
Social media draft guidance describes how and when interactive real-time promotional materials must be submitted for FDA review.
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Some stakeholders are concerned the agency’s draft guidance is overreaching and could have a chilling effect. AdvaMed recommends FDA consider splitting the guidance into product-specific documents to reference regulations that may apply to industries differently.
FDA is revealing its views on social media use through individual enforcement actions and provisions in disparate guidances, in the absence of issuing an overarching guidance. A recent warning letter sheds light on the agency’s view of “liking” something on Facebook.
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.