We propose a Center for Research on Complex Generics (CRCG), which will serve the public by working with the Food and Drug Administration (FDA) and the generic drug industry to identify and organize activities that promote the development of complex generics, including greater first cycle approvals. CRCG will be a science- based resource that adds to ongoing FDA Office of Generic Drugs (OGD) activities, with a focus on complex generics and opportunity to learn about, and contribute to, complex generic drug development. This viewpoint reflects the perspective that pre-competitive spaces in drug development science, including complex formulation science, are public spaces that require active public involvement. We will work with the best content experts to move pharmaceutical development science for more accessible medicines forward. The mission of the CRCG is to support the FDA's efforts to enhance research collaborations with the generic industry to further the FDA's mission of increasing access to safe and effective generic drugs. This mission will be pursued through collaborative research, training, and exchange. Stakeholders include FDA, the generic industry, and all others with an interest in better pharmaceutical development science for more accessible medicines. Activities include webinars, workshops, pilot laboratory projects to meet technique development needs, laboratory demonstrations, a Visiting Scientist Program, as well as a Complex Generics Scholars program and student events. The sum of these activities describe a vibrant, cutting edge Center that stimulates innovative thought, disseminates understanding of complex drugs and practices, and generates new knowledge in support of the FDA's fundamental mission ? to promote and protect the public health.
Statement We propose a Center for Research on Complex Generics that will support the Food and Drug Administration's (FDA's) efforts to enhance research collaborations with the generic industry, to further the FDA's mission of increasing access to safe and effective generic drugs. The Center for Research on Complex Generics will increase access to safe and effective generic drugs through collaborative research, training, and exchange. Activities leverage faculty expertise in formulation and evaluation of complex drugs, as well as exceptional laboratory and training space, to move the development and assessment of complex generics forward.