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New User Fee Laws Coming August 8, 2017

Posted by Michael Hamrell in Uncategorized.

The Congress has just voted and authorized the Prescription Drug User Fee Act (PDUFA) for another five years. The final bills to reauthorize all the user fee programs are waiting for the President to sign them. This law, originally passed in 1992, allows FDA to collect fees associated with submission and review of a New Drug (and Biologic) Applications 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, the development of pediatric information for labels and other initiative to encourage development of new drugs and expedite their review. The success of the PDUFA program for drugs (and biologics) led to the implementation of User Fees for medical devices in 2002 (MDUFMA) and starting in 2013, user fees for generic drugs, 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, 2017. Stay tuned for more details.


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