The Food and Drug Administration released two draft guidance documents for the drug and device industries on presenting risk/benefit information and correcting third-party misinformation on social media.
However, attorneys told Bloomberg BNA that the documents issued June 17 may not provide that much new information for FDA-regulated companies and have limited usefulness.
The agency asked that comments on both draft guidance documents be submitted by Sept. 16. The docket number for the guidance on presenting risk/benefit information is FDA-2014-D-0397 and the docket number for the guidance on correcting third-party misinformation is FDA-2014-D-0447. Notices announcing the draft guidances are to be ...
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