Description
Background The FDA's Office of Generic Drugs (OGD) implements the generic drug research program under the Generic Drug User Fee Amendments (GDUFA) in part by collaborating externally with various institutions. The GDUFA research program supports the development of new tools for FDA to evaluate generic drug equivalence and for industry to efficiently develop new generic products. In the re-authorization of GDUFA in 2017 (GDUFA II), FDA made a commitment to assist industry in the submission of an ANDA for a complex drug product by making improvements in the process for development of product-specific guidances and conduct of pre-ANDA meetings for complex products. As described in the GDUFA II Commitment Letter (https://www.fda.gov/media/101052/download ), complex products generally consist of: (1) products with complex active ingredients, complex formulations, complex routes of delivery, or complex dosage forms, (2) complex drug-device combination products, and (3) other products where complexity or uncertainty concerning the approval pathway or possible alternative approach would benefit from early scientific engagement. The development of guidances and recommendations (communicated through product-specific guidances and pre-ANDA meetings) require FDA to continually improve a strong scientific research program related to complex generic drug products. Each year, OGD posts research priorities for generic drugs on its webpage at: https://www.fda.gov/drugs/generic-drugs/generic-drugs-priorities-projects. As yearly research priorities for generic drugs are identified, FDA recognizes the need for improved collaborations with the generic industry to successfully address scientific gaps that may present barriers to generic product development and/or ANDA review. Therefore, the FDA is announcing this FOA to establish a Center for Research on Complex Generics with the goals of providing the following: (1) facilitation of engagement with generic industry to encourage participation in complex generics research, (2) coordination of research projects pertaining to complex generics with the generic drug industry, and (3) coordination of training, workshops, and other educational activities pertaining to complex generic drug research. These efforts will enable FDA to establish enhanced research collaborations with the generic industry to further the FDA's mission of increasing access to safe and effective generic drugs. This new center will complement FDA's existing regulatory science programs through its specific focus as a hub for coordination and engagement with the generic industry. Program Characteristics 1.Collaborative interactions to stimulate generic drug research engagement from the generic drug industry and accelerate progress in areas of high priority to OGD and the generic drug industry. Collaborative interactions may include: Scientific exchanges such as a visiting scientist program. FDA staff may visit the Center or a partner site to provide lectures and/or participate in workshops, spend time learning about new technologies or how to use new instrumentation and meet with program directors and interested scientific staff. Reciprocally, Center members may visit FDA to provide lectures and/or participate in workshops, visit FDA laboratories, and meet with FDA staff. These discussions may foster new collaborations/interactions with Center members and FDA. Industry scientists also may visit the Center to learn about new technology and aid the Center in developing research proposals that address scientific challenges in the generic drug industry. Such visits will be conducted consistent with all applicable laws, regulations and policies, to minimize conflicts of interest, or the appearance of conflicts of interest. In addition, any non-public information may only be shared as authorized by law and regulation. Workshops on generic drug research. These workshops should engage FDA, the Center and its members, the generic drug industry and the public. These workshops may be co-sponsored with the FDA, consistent with applicable policies regarding co-sponsorships. Scientific and educational workshops in partnership with FDA may be proposed for horizon scanning for emerging fields or trends in generic drug research to bring relevant stakeholders together and to accelerate understanding of different fields. Applicants need to demonstrate their ability to accomplish the collaborative interactions described above, as well as propose other types of interactions that would further engagement with the public, in particular, with the generic industry. 2. Infrastructure to support core program for the Center. Applicants must describe the proposed organizational structure to establish and support collaborations with other entities and individual investigators. 3. Cutting-edge scientific research in analytical methods, modeling and simulation, formulation science, clinical and pre-clinical development, and other areas pertaining to generic drug research. Applicants must demonstrate partnerships with scientific investigators who have expertise in these areas and understand the goals of the generic drug research program. Applicants should also demonstrate the ability to engage effectively with the generic drug industry. As noted on page 16, below, when research resources have been developed with FDA funds and the associated research findings published, those findings must be made readily available to the scientific community.