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Updated PDUFA Law is Coming May 27, 2012

Posted by Michael Hamrell in Regulatory Thoughts.

The Congress is in the process of voting and reauthorizing the Prescription Drug User Fee Act (PDUFA) for another five years. This law, originally passed in 1992, allows FDA to collect fees associated with submission and review of a New Drug Application along with product and establishment fees. The Act requires that Congress reauthorize the law every five years. Each cycle, the reauthorization has included a review and reexamination of FDA progress in meeting review goals and protecting the public. Over the years, new aspects of FDA oversight have been included as part of the reauthorization, including the addition of REMS, requirements for post-approval studies and the development of pediatric information for labels. The success of the PDUFA program for drugs (and biologics) led to the institution of User Fees for medical devices in 2002 (MDUFMA). New for 2013 going forward will be user fees for generic drugs for the first time, as well as a novel structure for user fees for biosimilar products. The law is expected to be finalized this summer to be ready for implementation in the next Fiscal Year, starting October 1, 2012. Stay tuned for more details.



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