Today the U.S. Food and Drug Administration (FDA) announced that the Generic Drug User Fee Amendments (GDUFA) Science and Research Program has awarded a grant to the Universities of Maryland and Michigan to establish the Center for Research on Complex Generics. The $5 million-dollar grant, which will be awarded over five years, aims to enhance research collaborations with the generic drug industry to further the FDA’s mission of increasing access to safe, effective, and high-quality generic products. This goal will be pursued through collaborative research, training, and exchange of resources between FDA, the generics industry, and stakeholders.
FDA established the Drug Competition Action Plan (DCAP) in 2017 to further encourage robust and timely market competition for generic products and help bring greater efficiency and transparency to the generic drug review process. A key component of DCAP is to maximize scientific and regulatory clarity with respect to complex generic products, products that were not foreseen in 1984 at the time of the Hatch-Waxman Amendments, which established the generic drug approval pathway. Complex products are medical products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement, such as products with complex active ingredients and drug-device combination products. These products are, in general, harder to develop with traditional bioequivalence methods and therefore fewer exist, resulting in less market competition for these products.
The Center for Research on Complex Generics aims to support the generic drug industry and other stakeholders by offering collaborative research and training through webinars, workshops, laboratory projects to meet development needs, and a Complex Generics Scholars program, among other initiatives. This first of its kind, cutting-edge center will stimulate innovative dialogue, disseminate current understanding of complex products and practices, and generate new knowledge in support of FDA’s mission to promote and protect the public health by increasing access to safe and effective generic medicines.
For more information about the grant and the Center for Research on Complex Generics, please visit https://www.fda.gov/drugs/guidance-compliance-regulatory-information/center-research-complex-generics.
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