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.
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Guidance on scientific exchange is on the horizon; agency “carefully evaluating” existing advertising policies following recent court decisions.
Comparative claims to distinguish a product are triggering FDA enforcement letters; companies also face risks when interacting more with patients.
The draft guidance outlines substantial reporting requirements for websites that firms control and for content on third-party sites – as well as saying when FDA intends to use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.