July 11, 2012

FDA user fees legislation signed into law

President Obama signed the Food and Drug Administration user fees bill into law on Monday. The measure reauthorizes user fees paid by medical device and drug companies and creates new user fee programs for generic drugs and bio-similar (or follow-on biologic) drugs. In addition, the measure creates regulatory provisions affecting drugs and devices. These include antibiotic development incentives, shortage prevention provisions and new guidance for related social media activities.
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