Social Media Guidance Gives Drug Firms A Pass On User Content
This article was originally published in The Tan Sheet
The draft guidance outlines substantial reporting requirements for websites that firms control and for content on third-party sites – as well as saying when FDA intends to use enforcement discretion.
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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.
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