(FOA)-Center
for Collaborative Research on Complex Generics (U18) Clinical Trials Optional;
April 13, 2020
Agency
U.S.
Food and Drug Administration
Description
The
Food and Drug Administration (FDA) seeks to establish a Center for Research on
Complex Generics under the terms and conditions of a cooperative agreement. The
Center for Research on Complex Generics will 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. Program
characteristics include:
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 such as:
·
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.
·
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.
Announcement
Number:
RFA-FD-20-007
Closing
Date:
April
13, 2020
Link
to Full Announcement
https://grants.nih.gov/grants/guide/rfa-files/RFA-FD-20-007.html
Contact
Information
Stephanie
Choi
240-402-7960