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There'll be some changes made: President signs prescription drug and biologic user fee reauthorization act

21 August 2017

Pharmaceutical Client Alert
On August 18, 2017, President Trump signed into law the FDA Reauthorization Act (FDARA). FDARA reauthorizes user fees paid to FDA to support regulatory review of innovator drugs and biologics, medical devices, generic drugs, and biosimilar biologics.

The fees fund FDA’s review of premarket approval applications, and related regulatory activities, for new medical products. In exchange, the Agency agrees to meet certain goals negotiated with industry representatives. The negotiated goals are listed in separate FDA documents that are incorporated into the statute by reference. On top of the user fee program changes agreed to by the Agency and industry, Congress introduced numerous provisions affecting the agency.

Our summary highlights the most significant provisions relating to pharmaceuticals and biotechnology products.

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