FDA’s Social Media Guidance Gives Firms A Pass On User-Generated Content
The draft guidance outlines substantial reporting requirements for websites that firms control and for content on third-party sites – as well as saying when FDA intends to use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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House 21st Century Cures discussion draft would adjust FDA promotion regulations for Twitter, requiring that information communicated through hyperlink be considered part of the original post.
Agency originally said it would issue a draft guidance on industry’s interactions with formulary committees in 2014, but CDER Director Woodcock says “extremely contentious” issues have slowed progress.
Draft guidances say tweets about a product must balance benefit and risk information, and firms cannot be selective in correcting information on third-party sites.