To proactively address challenges presented by advanced and continuous manufacturing technologies, FDA representatives actively participate in ongoing public-private partnerships. These partnerships include U.S. government agencies, academia, research institutes, and industry. Examples of these partnerships include federally supported advanced development and manufacturing centers, the Manufacturing USA Institutes, and America Makes.
Manufacturing USA is a network of 16 regional institutes, each with a specialized technology focus. The institutes share one goal: to secure the future of manufacturing in the U.S. through innovation, collaboration, and education. Each institute is designed to be a public-private membership organization that provides vision, leadership, and resources to its members. Its goals are to enhance industrial competitiveness, increase economic growth, and strengthen U.S. national security.
FDA’s Medical Countermeasures Initiative (MCMi) and other FDA centers and offices are actively involved in Manufacturing USA Innovation Institutes (MIIs) including BioFab USA, NIIMBL, and America Makes.
BioFab USA is an MII run by the Advanced Regenerative Manufacturing Institute (ARMI). ARMI’s mission is to make the large-scale manufacturing of engineered tissues and tissue-related technologies more accessible/practical, benefiting existing industries and grow new ones.
BioFabUSA works to integrate innovative cell and tissue cultures with advances in biofabrication, automation, robotics, and analytical technologies to create disruptive research and development tools and FDA-compliant volume manufacturing processes.
National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL)
NIIMBL is a public-private partnership dedicated to advancing biopharmaceutical manufacturing innovation and workforce development, funded by a cooperative agreement with the National Institute of Standards and Technology (NIST) in the U.S. Department of Commerce and with additional support from industry partners. NIIMBL seeks to 1) accelerate the translation and adoption of innovations in biopharmaceutical manufacturing that will positively impact the safety, quality, rapid accessibility and secure supply of biologic medicines, 2) support the development of standards and regulatory science that will ensure consistent, high quality products, and 3) support the development of a highly-skilled workforce trained to support the biomanufacturing and regulatory community.
NIIMBL facilitates collaboration between partners from industry, academia, non-profits, and government agencies to:
- Advance innovative manufacturing technologies to bring life-saving and life-enhancing biologics products to market faster and at reduced cost,
- Establish reference standards and measurement technologies to enhance efficiencies, and
- Cultivate a world-leading biopharmaceutical workforce through novel training and education programs.
FDA and NIIMBL participate in a Collaborative Research and Development Agreement (CRADA) which creates a research partnership, in the pre-competitive space, to support research, development, testing and training in the field of advanced manufacturing innovations to enhance the biopharmaceutical manufacturing ecosystem.
- Through this mechanism, FDA researchers can collaborate with NIIMBL members to respond to NIIMBL project calls with proposals initiated either within the Agency or by a NIIMBL member. Also see Funding opportunities
- FDA researchers should refer to the Advanced Manufacturing Technologies Working Group for more information on how to apply.
America Makes is a national accelerator for additive manufacturing and 3D printing. Managed and operated by the non-profit National Center for Defense Manufacturing and Machining (NCDMM), America Makes is a public-private partnership with member organizations from industry, academia, government, non-government agencies, and workforce and economic development resources working together to innovate and accelerate additive manufacturing and 3D printing to increase our nation’s global manufacturing competitiveness.
FDA is a member of America Makes and participates in research, developing voluntary standards, and road-mapping activities to foster high quality innovation in 3D-printed medical products.
FDA continues to take creative and flexible approaches to address availability of critical medical products in response to the COVID-19 pandemic. In addition, non-traditional manufacturers and community responders have helped address shortages and gaps in medical supplies during the COVID-19 pandemic, and yielded millions of pieces of equipment and supplies, such as masks, face shields, and other 3D-printed medical devices.
In September 2020, FDA funded a study, conducted by America Makes, to summarize the impact of 3D printing on the overall COVID-19 response. FDA has made publicly available this report on the use of additive manufacturing by non-traditional producers in support of the U.S. COVID-19 response. The study shows successes, challenges, and key lessons learned to build on and improve future crisis response. FDA is reviewing the report to assess gaps in the response and potential mitigations for future public health emergencies. Read more about this project at: Advanced Manufacturing Research and Projects.
In May 2023, FDA and the Veterans Health Administration announced a new collaboration to jointly develop emergency preparedness and response tools and protocols intended to help increase medical product manufacturing capacity and flexibility, and improve resilience of domestic supply chains during emergencies, shortages, and pandemics. A Memorandum of Understanding (MOU) will help facilitate the development of requirements for trusted networks needed to enable the use of distributed manufacturing and digital stockpiles, which could ultimately enable veterans and civilians to more rapidly access innovative medical products to support their care. This MOU is specific to medical devices and accessories that may be made using advanced and distributed manufacturing methods. Learn more, including descriptions of these advanced manufacturing approaches.
COVID-19 and other disruptions have highlighted the need for a more resilient drug supply chain. Manufacturing quality issues, natural disasters, bioterrorism, geopolitical issues, and other supply and demand shocks all pose threats to U.S. patients in need of life-saving essential drugs. As of April 2023, more than 100 drugs are currently on the FDA drug shortage list, and adverse patient outcomes, including increased mortality rates and medication errors, are occurring too frequently.
The Drug Supply Chain Resilience and Advanced Manufacturing Consortium mission is to identify effective policy solutions that promote a resilient drug supply chain with advanced manufacturing capabilities and, ultimately, reduce the frequency and severity of drug shortages. Based on input from a wide range of experts involved in manufacturing, distributing, purchasing, prescribing, and regulating prescription drugs, the Consortium will put forward written policy recommendations and other work products as necessary to advance these aims. We look forward to working together to build a drug supply chain that ensures patients access to safe and effective drugs, in adequate quantities, when they’re needed.
- 3D Printing in FDA’s Rapid Response to COVID-19
- FDA Efforts to Connect Manufacturers and Health Care Entities: The FDA, Department of Veterans Affairs, National Institutes of Health, and America Makes Form a COVID-19 response Public-Private Partnership
Information from other partners
- NIH 3D Print Exchange - offers a unique set of models, learning resources and tutorials to create and share 3D-printable models related to biomedical science
- Advanced Manufacturing National Program Office, National Institute of Standards and Technology (NIST)
- Mind the Gap: Bridging the ‘Valley of Death’ for U.S. Biomanufacturing (NIST, January 2020)