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OCET Advanced Manufacturing Program

Advanced manufacturing is a collective term for new medical product manufacturing technologies that can improve drug quality, address shortages of medicines, and speed time-to-market. The OCET Advanced Manufacturing Program aims to help FDA develop regulatory science tools and metrics, and facilitate industry adoption of these emerging technologies—especially to improve public health emergency response and supply chain resilience.

The Office of Counterterrorism and Emerging Threats (OCET), in the Office of the Chief Scientist, published a new website section with additional information about its advanced manufacturing program, including new pages about the I-TEAM Hub collaboration with HHS/ASPR, a smart design and manufacturing pilot program, and a partnership with the National Institute of Standards and Technology (NIST) to develop and benchmark methods to predict thermal stability of monoclonal antibodies. The section also includes new pages about advanced manufacturing research and projects, and public-private partnerships. The existing Advanced Manufacturing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA.

Computational modeling and simulation (M&S) are powerful tools that complement traditional methods for gathering evidence about products regulated by FDA. FDA scientists routinely review results from M&S studies submitted by industry, and use M&S approaches for scientific research and regulatory decision-making. In November 2022, FDA published a new report including case studies from across FDA, illustrating how these technologies help FDA fulfill our mission.

FDA's Office of Minority Health and Health Equity (OMHHE) has posted a funding opportunity for COVID-19 research that will strengthen and advance research in minority health and healthy equity, increase understanding of health disparities, and provide future direction for research that will contribute to regulatory decision making. OMHHE is interested in research proposals that will contribute to advancing understanding of COVID and long COVID or post-COVID conditions for racial and ethnic minorities or contribute to informing the continued evaluation of the safety and efficacy of FDA approved products (therapeutics, diagnostics, and vaccines) for the treatment, prevention, or diagnosis of COVID-19. These research proposals should support evaluation of outcomes by demographic data including, but not limited to, ethnicity, race, age, disability and geography. Letters of intent are due by December 6, 2022, and applications are due by January 16, 2023.

Apply to become FDA's next CERSI partner

FDA works with partners to advance regulatory science through innovative research, training, and scientific exchanges. One way we do this is through Centers of Excellence in Regulatory Science and Innovation (CERSIs), which focus on cutting-edge, collaborative regulatory science research, and encourage information sharing. The FDA Office of Regulatory Science and Innovation (ORSI), in the Office of the Chief Scientist, is seeking applications for the CERSI program. Applications are due by December 22, 2022.