New and Generic Drug User Fees, 21st Century Cures Act, Fuel FDA Regulatory Process and Culture Changes for Combination Products

The process of reauthorizing user fees for new and generic drug products has afforded the Center for Drug Evaluation and Research (CDER) the opportunity to work cooperatively with industry to drive significant cultural and process enhancements in its regulation of drug/biologic/device combination products.

Commitments related to improving the regulatory process for combination products are built into the legislation to reauthorize the prescription and generic drug user fee acts for FY 2018 through 2022 (PDUFA VI and GDUFA II).

The reauthorization bill – which also encompasses the renewal of user fees for biosimilars (BSUFA II) and medical devices (MDUFA IV) – is nearing clearance, with the Senate’s Committee on Health, Education, Labor & Pensions voting 21 to 2 in favour of adoption in mid-May. Congress has been targeting final passage before its summer recess.

During the extensive negotiations, FDA and industry agreed that combination product (CP) review transparency and coordination among the drug, biological and device centers could be improved and that more dedicated funding streams were needed to fuel the improvements. The negotiations reflected the shared recognition that combination products are a transformative aspect of healthcare, deserving the kind of regulatory support that has been allotted to breakthrough therapies.

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