On August 1, 2020 the FDA awarded a five-year grant to the University of Maryland and the University of Michigan to establish a Center for Research on Complex Generics (CRCG). The center aims to enhance research collaborations with the generic industry to further the FDA's mission of increasing access to safe and effective generic products. This goal will be pursued through collaborative research, training, and exchange of resources between FDA, the generics industry, and stakeholders.
CRCG aims to support the generic industry and other stakeholders by offering:
- collaborative research and training,
- laboratory projects, 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.
Complex products, which are a key component of the FDA’s Drug Competition Action Plan, 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 are products that were not foreseen in 1984 at the time of the Hatch-Waxman Amendments, which established the generic drug approval pathway. Complex generics products are, in general, harder to develop with traditional bioequivalence methods and therefore fewer exist, resulting in less market competition for these products.
The grant period for the CRCG, which will be run primarily by the University of Maryland and the University of Michigan with support from FDA, is from August 1, 2020, until July 31, 2025.
Upcoming and Recent Events:
- November 30, 2021: Establishing the Suitability of Model-Integrated Evidence to Demonstrate Bioequivalence for Long-Acting Injectable and Implantable Drug Products
- Aug. 18-20, 2021: In Vitro Release Test (IVRT) and In Vitro Permeation Test (IVPT) Methods: Best Practices and Scientific Considerations for ANDA Submissions
- Sept. 30 – Oct. 1, 2021: Regulatory Utility of Mechanistic Modeling to Support Alternative Bioequivalence Approaches