After months of negotiations, on July 9, 2012, President Obama
signed bipartisan legislation that authorizes the U.S. Food and
Drug Administration (FDA) to assess user fees to support the
agency's review of marketing applications for drugs, biologics
and medical devices. The law, known as the Food and Drug
Administration Safety and Innovation Act, is available here. As with previous versions of user
fee legislation, the final law also includes several provisions
related to the FDA's review and oversight of regulated
products. This White Paper provides a brief overview
of the manner in which the bill originally approved by the Senate,
the bill originally approved by the House and the enacted law
address various issues related to the regulation of drugs, medical
devices and biologics.
Please click
here to view the entire White Paper in Adobe PDF format.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
Specific Questions relating to this article should be addressed directly to the author.
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