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FDA User Fees Reauthorized July 10, 2012

Posted by Michael Hamrell in Regulatory Thoughts.

The FDA Safety and Innovation Act was signed into law by the President on July 9, 2012. This law reauthorizes user fees for device and drugs and establishes user fees for biosimilar products and generic drugs. There are also a number of other initiatives and incentives added to FDA Law. One of the key points is that in the next few years all submissions to FDA for drugs and biologics will have to be electronic, no more paper submissions.

More details to follow as the final details are published.



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