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.
