Advanced Manufacturing
FDA news, events, and funding opportunities related to advanced manufacturing
On this page: What's new | What is advanced manufacturing? | Press, statements, and publications | Events | Funding opportunities | Guidance and information for industry | Contact FDA
What's new
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November 21, 2022: 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. Today, 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. This existing page will continue to include advanced manufacturing news, events, and funding opportunities from across FDA.
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November 14, 2022: FDA has posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For more information and areas of interest, including advanced manufacturing, see the full BAA PDF (788 KB - link updated). We invite interested applicants to join us for FDA BAA Day on December 6, 2022, to learn more about the application process. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023.
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October 13, 2022: FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing - FDA's Center for Drug Evaluation and Research (CDER) has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. This discussion paper presents areas associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper considers relevant background, including terminology, to the FDA’s regulation of DM and POC, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment. FDA is seeking input on each of these topics and on 20 questions posed in the discussion paper. FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316, by December 13, 2022. Also see: CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
What is advanced manufacturing?
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. Learn more: Advanced Manufacturing for Public Health Emergency Preparedness and Response
Press, statements, and publications
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October 13, 2022: FDA Seeks Feedback on Distributed and Point-of-Care Drug Manufacturing - FDA's CDER has issued a discussion paper, Distributed Manufacturing and Point-of-Care Manufacturing of Drugs. This discussion paper presents areas associated with distributed manufacturing (DM) and point-of-care (POC) manufacturing that FDA has identified for consideration as FDA evaluates our existing risk-based regulatory framework as it applies to these technologies. The discussion paper does not constitute guidance; instead, its purpose is to gather feedback from the public to inform future policy development. The discussion paper considers relevant background, including terminology, to the FDA’s regulation of DM and POC, identifies challenges presented by DM and POC, and poses key questions to facilitate public comment. FDA is seeking input on each of these topics and on 20 questions posed in the discussion paper. FDA encourages stakeholders to provide comments under docket number FDA-2022-N-2316, by December 13, 2022. Also see: CDER’s Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative
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October 7, 2022: The White House released the National Strategy for Advanced Manufacturing (PDF, 1,040 KB). Goals of the strategy are to 1) Develop and implement advanced manufacturing technologies, 2) Grow the advanced manufacturing workforce, and 3) Build resilience into manufacturing supply chains and ecosystems.
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September 14, 2022: The U.S. Department of Health and Human Services (HHS) announced actions the department will take following the Executive Order signed September 12, 2022 by President Biden launching a National Biotechnology and Biomanufacturing Initiative (NBBI). In its implementation of the Executive Order, HHS intends to leverage biotechnology and biomanufacturing in order to achieve medical breakthroughs, reduce the overall burden of disease, and improve health outcomes. HHS will lead the U.S. government in strategically advancing biosafety and biosecurity innovation as part of a growing bioeconomy, to ensure biotechnology research and development and biomanufacturing infrastructure break new ground while reducing risk. This includes supporting development of the Advanced Manufacturing Innovation Hub in the FDA’s Office of Counterterrorism and Emerging Threats (OCET) to facilitate creation of regulatory science benchmarks and strategies for platform technologies and to drive collaborations that affect multiple product areas (e.g., smart manufacturing, closed loop process controls).
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June 28, 2022: An FDA Self-Audit of Continuous Manufacturing for Drug Products (podcast and newsletter) - Continuous manufacturing (CM) technology has the potential to improve product quality and reliability, lower manufacturing costs, reduce waste, decrease inventory, and increase manufacturing flexibility and agility in response to product demand. Alternatively, is it possible that CM can also increase time to regulatory approval and market entry, hinder submission of post-approval changes, and raise inspectional scrutiny? CDER’s Office of Pharmaceutical Quality (OPQ) set out to find answers by conducting a self-audit of approved U.S. regulatory submissions that employ CM vs. traditional batch processes, and analyzing regulatory outcomes during the product lifecycle and at approval.
- February 23, 2022: FDA's CDER Office of Pharmaceutical Quality (OPQ) published its 2021 Annual Report (PDF, 3.6 MB), including an update on the Emerging Technology Program.
- December 10, 2021: FDA In Brief: FDA Publishes Discussion Paper and Seeks Public Input on 3D Printing of Medical Devices at the Point of Care - FDA published a discussion paper regarding 3D printing medical devices at the point of care (PoC), such as hospitals and doctor’s offices.
- November 10, 2021: Trust in the Time of Covid-19: 3D Printing and Additive Manufacturing (3DP/AM) as a Solution to Supply Chain Gaps - FDA and partners published a commentary in NEJM Catalyst Innovations in Care Delivery on how a public-private collaboration, Covid 3D TRUST, has helped to address critical supply shortages by empowering designers, manufacturers, and users of 3D-printed personal protective equipment (PPE) during the COVID-19 pandemic.
- October 13, 2021: FDA’s Advanced Manufacturing Initiatives Helping to Provide Quality Human Drugs for Patients - FDA has long recognized the importance of advanced manufacturing. The FDA has received significant funding from Congress for advanced manufacturing-related projects, and we continue to work with manufacturers looking to implement these new technologies to benefit even more patients. To do so, the Center for Drug Evaluation and Research (CDER) has established numerous initiatives, including the development of a research program to better understand the science of advanced manufacturing. To date, this program has fueled nearly 60 research projects, including many collaborations with experts in the field. Read more: FDA Voices
- August 20, 2021: Impact of Continuous Manufacturing Processes on the Viral Safety of Therapeutic Proteins - FDA/CDER researchers are working to ensure the safety of therapeutic proteins produced by continuous manufacturing.
- January 15, 2021: Accelerating the Adoption of Advanced Manufacturing Technologies to Strengthen Our Public Health Infrastructure - FDA is creating a new collaboration with the National Institute of Standards and Technology (NIST) through a memorandum of understanding (MOU). This MOU is intended to increase U.S. medical supply chain resilience and advanced domestic manufacturing of drugs, biological products and medical devices through adoption of 21st century manufacturing technologies. These include smart technologies, such as artificial intelligence and machine learning, and emerging manufacturing processes. The MOU signals alignment between senior leadership at both institutions in recognition of the importance of modernizing regulatory frameworks as well as industry practices to meet public health needs in the U.S.
- December 15, 2020: FDA Insight podcast: Advanced Manufacturing - Dr. Jeffrey C. Baker, Deputy Director of the FDA’s Office of Biotechnology Products in the Center for Drug Evaluation and Research, joins Dr. Shah for a discussion on how FDA’s efforts help innovation and implementation of Advanced Manufacturing technologies regarding food and drug safety.
- October 30, 2020: FDA Publishes List of Essential Medicines, Medical Countermeasures, Critical Inputs Required by Executive Order - An August 2020 executive order directed FDA, in consultation with federal partners, to identify a list of essential medicines, medical countermeasures and critical inputs that are medically necessary to have available at all times in an amount adequate to serve patient needs and in the appropriate dosage forms. The executive order also directs the FDA to coordinate with our federal partners on a number of additional issues, including strategies for acquiring the products on the list, accelerating domestic manufacturing, and identifying and addressing supply chain vulnerabilities.
- August 3, 2020: Investing in Advanced Manufacturing to Support Public Health Preparedness - The potential public health value of advanced manufacturing is even greater in the context of the ongoing COVID-19 pandemic, which has highlighted the strain on supply chains and the need for adaptive manufacturing systems to accelerate the production of medical countermeasures. The FDA has established a strong regulatory foundation to support the uptake of advanced manufacturing, and COVID-19 provides the unique impetus to spur further advancement of medical manufacturing.
- June 19, 2020: 3D Printing in FDA’s Rapid Response to COVID-19 - FDA published a new web page, with updates on activities performed under the FDA, NIH, and VA Memorandum of Understanding (MOU) in collaboration with America Makes, signed in March 2020.
- January 14, 2020: Mind the Gap: Bridging the ‘Valley of Death’ for U.S. Biomanufacturing, a blog post from the National Institute of Standards and Technology (NIST), includes information about FDA collaborations to help innovate U.S. biomanufacturing.
- October 30, 2019: Janet Woodcock, MD, Director of the FDA Center for Drug Evaluation and Research (CDER), testified before the House Committee on Energy and Commerce, Subcommittee on Health, on Safeguarding Pharmaceutical Supply Chains in a Global Economy. Dr. Woodcock's statement includes information about advanced manufacturing, including medical countermeasure manufacturing, and implications for national security.
- July 31, 2019: NIIMBL and FDA Sign Agreement to Support Innovation in Biopharma Manufacturing - The National Institute for Innovation in Manufacturing Biopharmaceuticals (NIIMBL) announced that the University of Delaware, on behalf of NIIMBL, has entered into a Collaborative Research and Development Agreement (CRADA) with the FDA. Effective July 15, 2019, the FDA and NIIMBL will have the ability to collaborate in a pre-competitive environment to strengthen research, innovation, training, and collaboration in the biopharmaceutical manufacturing industry.
- March 19, 2019: Nondestructive Analytics for Biologics and Continuous Biomanufacturing lecture recording, presented by Bruce Yu, PhD, Professor, Pharmaceutical Sciences and Director, Bio- and Nano-Technology Center, University of Maryland School of Pharmacy - In this CERSI lecture, Dr. Yu provided background on a nondestructive analytical technology, Water proton NMR (wNMR), discussed examples of applying wNMR to inspect FDA-approved biologics (vaccines, vaccine adjuvants, and a therapeutic protein) and a non-biologic complex drug (Ferrlecit), and described how wNMR can be used to improve continuous biomanufacturing.
- February 28, 2019: FDA's Center for Drug Evaluation and Research (CDER), Office of Pharmaceutical Quality (OPQ) published its 2018 annual report (PDF, 5.3 MB). Among other innovations, in 2018, FDA approved two New Drug Applications (NDAs) based on continuous manufacturing. This type of manufacturing eliminates breaks between steps during the process of making a drug. Among other things, this reduces opportunities for human errors during the stops and starts in a process.
- February 26, 2019: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing (FDA news release) One of today’s most important tools for modernizing the pharmaceutical industry is a process known as continuous manufacturing. This approach transforms the traditional, step-wise manufacturing processes into a single system that’s based on modern process monitoring and controls. It enables a steady output of finished drug products as raw materials are continuously added to the closed system. Today, we’re taking new steps to help advance the adoption of these manufacturing innovations.
- February 13, 2019: Statement from FDA Commissioner Scott Gottlieb, M.D. on new programs to promote the adoption of innovations in drug manufacturing that can improve quality and lower drug costs (FDA news release)
- September 20, 2018: FDA awards grants to foster innovation for advanced manufacturing technology as part of the agency’s efforts to ensure a robust and reliable supply of biological products (FDA in Brief)
- August 1, 2018: FDA supports critical research to spur innovation for continuous manufacturing technology to support and advance drug and biologics development (FDA in Brief, on grants awarded)
- July 13, 2018: FDA Budget Matters: Investing in Advanced Domestic Manufacturing (FDA Voices, by Scott Gottlieb, M.D.)
- December 4, 2017: Statement by FDA Commissioner Scott Gottlieb, M.D., on FDA ushering in new era of 3D printing of medical products; provides guidance to manufacturers of medical devices
- September 28, 2017: FDA issues guidance to help advance novel technology to improve the reliability and safety and help lower the cost of pharmaceutical manufacturing (FDA in Brief)
- September 11, 2017: “Continuous Manufacturing” – Common Guiding Principles Can Help Ensure Progress (FDA Voice blog – ARCHIVED)
Events
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December 6, 2022: FDA Broad Agency Announcement Day - Join us to learn more about the application process for the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. Areas of interest include advanced manufacturing. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023.
- November 14-16, 2022: FDA/PQRI Workshop on the Regulatory Framework for Distributed and Point of Care Pharmaceutical Manufacturing: An Opportunity for DM/POC Stakeholder Engagement (virtual) - To facilitate interaction among distributed manufacturing (DM)/ point of care (POC) stakeholders on critical areas for development and implementation of DM and POC technologies including terminology, technical challenges to adoption, operation of Pharmaceutical Quality Systems, good manufacturing practice expectations, and the unique challenges and considerations that apply to complex biologics.
- September 20-22, 2022: 2022 Center for Biologics Evaluation and Research (CBER) Science Symposium (12:00 - 4:00 p.m. ET, virtual) - To discuss scientific topics related to the regulation of biologics and highlight science conducted at CBER by showcasing how scientific research informs regulatory decision making, and to provide a forum for developing collaborations within FDA and with external organizations. The agenda includes a session on advanced manufacturing.
- September 12-13, 2022: DIA-USFDA-PMDA-TGA-CDSCO Advanced Manufacturing Workshop (virtual, 5:30 - 9:30 a.m. EDT) - Embracing The Future: Regulatory Considerations And Industry Perspectives On Advanced Manufacturing - FDA's India Office and the Drug Information Association (DIA) India Office will host a two-day workshop on regulatory policies, guidance, and support for the adoption of advanced manufacturing technologies.
- August 11, 2022: 2022 FDA CVM Advanced Manufacturing Public Meeting, 1:00 - 4:00 p.m. EDT - FDA's Center for Veterinary Medicine (CVM) will host a virtual public meeting on the FDA’s oversight of advanced manufacturing technologies for animal drugs. The meeting will be a listening session to provide stakeholders with an opportunity to share information and insight on this topic with CVM. Learn more: FDA Announces Virtual Public Meeting on Advanced Manufacturing for Animal Drugs
- March 16-17, 2022: Virtual Public Workshop - 3D Printing in Hospitals: Veteran’s Health Administration’s Experiences in Point of Care 3D Printing of Device and Implementing a Quality Management System, 12:00 p.m. - 5:30 p.m. ET both days - FDA is announcing a virtual public workshop in collaboration with the Veteran’s Health Administration (VHA) to share VHA’s experiences using 3D printing/additive manufacturing in their hospitals. The workshop is also intended to provide a forum for VHA and other stakeholders to present and discuss their experience that could be useful for health care facilities considering 3D printing medical devices. To attend, register by March 14, 2022.
- May 15, 2020: Virtual Town Hall - 3D Printed Swabs, 1:00 - 2:00 p.m. ET - will host a virtual Town Hall for researchers, clinical laboratories, and commercial manufacturers to discuss the production and use of 3D printed swabs during the COVID-19 public health emergency. This is a collaboration between the FDA, the Department of Veterans Affairs’ (VA) Innovation Ecosystem, and the National Institutes of Health’s (NIH) 3D Print Exchange.
- March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of advanced manufacturing technologies and methodologies, and discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
- March 19, 2019: Nondestructive Analytics for Biologics and Continuous Biomanufacturing lecture recording, presented by Bruce Yu, PhD, Professor, Pharmaceutical Sciences and Director, Bio- and Nano-Technology Center, University of Maryland School of Pharmacy - In this CERSI lecture, Dr. Yu provided background on a nondestructive analytical technology, Water proton NMR (wNMR), discussed examples of applying wNMR to inspect FDA-approved biologics (vaccines, vaccine adjuvants, and a therapeutic protein) and a non-biologic complex drug (Ferrlecit), and described how wNMR can be used to improve continuous biomanufacturing.
- March 12, 2020: Modernization of Pharmaceutical Manufacturing through the Adoption of Advanced Technology (Silver Spring, MD and webcast)- Hosted by FDA, this presentation will provide an overview of these advanced manufacturing technologies methodologies, discuss the many steps the FDA is taking to help realize the potential of advanced manufacturing, and highlight success stories of successful implementation of advanced manufacturing which holds great potential for improving the quality assurance of drugs.
- October 10, 2018: Manufacturing USA: Securing U.S. Global Leadership in Advanced Manufacturing, hosted by the House and Senate Manufacturing Caucus, and sponsored by American Society for Mechanical Engineers
- July 30-31, 2018: Continuous Manufacturing for the Modernization of Pharmaceutical Production, co-hosted by FDA and BARDA, with the National Academies of Sciences, Engineering, and Medicine, to discuss the business and regulatory concerns associated with adopting continuous manufacturing techniques to produce biologics (e.g., enzymes, monoclonal antibodies, and vaccines) and discuss specific challenges for process integration across the manufacturing system
Funding opportunities
FDA funding
FDA funds research and development to support regulatory science and innovation under the FDA Broad Agency Announcement (BAA). Advanced manufacturing opportunities may be submitted under research area I: Modernize development and evaluation of FDA-regulated products. For more detail, and information on funding deadlines for the current fiscal year, see Extramural Research.
FDA funding updates
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November 14, 2022: FDA has posted the FY23 FDA Broad Agency Announcement (BAA) for Advanced Research and Development of Regulatory Science. For more information and areas of interest, including advanced manufacturing, see the full BAA PDF (788 KB - link updated). We invite interested applicants to join us for FDA BAA Day on December 6, 2022, to learn more about the application process. For funding consideration in FY 2023, submit white papers by 5:00 p.m. EST, January 23, 2023.
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October 7, 2021: CDER recently awarded five new extramural research projects totaling over $11 million in advanced pharmaceutical manufacturing areas. The results produced from the extramural research projects are instrumental to the success of CDER initiatives, programs and activities in advanced pharmaceutical manufacturing. These results will be used to evaluate regulatory submissions incorporating advanced pharmaceutical manufacturing (e.g., development of regulatory recommendations for the industry to guide its product and technology development under CDER Emerging Technology Program), provide knowledge necessary to inform new standards, guidances and policies, develop new tools for more effective surveillance of product quality, and develop materials for training of FDA staff in advanced pharmaceutical manufacturing.
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Integrated toolbox for digital design, scale-up, control and optimization of advanced API manufacturing processes – Rutgers University
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Application of smart data analytics for biomanufacturing – Massachusetts Institute of Technology
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Controlled protein capture via continuous crystallization and precipitation for monoclonal antibody manufacturing - – Massachusetts Institute of Technology
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Assessment tools for surveillance and monitoring of real-world data systems and processes to ensure product quality – Purdue University
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Economics and Risks Associated with FDA’s Quality Management Maturity (QMM) Program – University of Maryland
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October 1, 2021: FDA's Office of Counterterrorism and Emerging Threats (OCET) collaborated with the Center for Devices and Radiological Health (CDRH) to award a contract to Siemens Government Technologies (SGT) to implement advanced industrial software for digital design and an automated manufacturing production demonstration line for regulatory science use in the FDA OCET advanced manufacturing program. The digital showcase will help facilitate evaluation, education, and industry adoption of smart design and manufacturing processes, which can improve performance, speed regulatory review, reduce supply shortages, and increase supply chain resilience in the life sciences industry.
- September 29, 2021: CBER has funded new FY21 grants to enhance innovations in advanced manufacturing technologies for vaccines against influenza and emerging infectious diseases (four grants), and to support vector manufacturing for diseases affecting very small populations (five grants).
Other funding
- BARDA’s DRIVe program to revolutionize the way we prevent, detect, and respond to major 21st century health security threats with several focus areas
- Manufacturing USA funding opportunities
- BioFab USA project calls
- NIIMBL project calls
- America Makes opportunities (challenges, RFPs, etc.)
Guidance and information for industry
Recently updated guidance documents specific to advanced manufacturing include:
- October 2021: FDA announced the availability of a draft ICH guidance for industry titled Q13 Continuous Manufacturing of Drug Substances and Drug Products. The guidance, which was prepared under the support of the International Council for Harmonisation (ICH), describes scientific and regulatory considerations for the development, implementation, and operation of continuous manufacturing. Submit comments by December 13, 2021.
- June 2019: FDA has reopened the comment period for the draft guidance Quality Considerations for Continuous Manufacturing.
- February 2019: Draft guidance - Quality Considerations for Continuous Manufacturing, to clarify the FDA’s current thinking regarding innovative CM approaches and can help resolve potential issues some companies have as they consider implementation. Also see: Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center for Drug Evaluation and Research on FDA’s modern approach to advanced pharmaceutical manufacturing
- December 2017: Technical Considerations for Additive Manufactured Medical Devices (on 3D printing)
- September 2017: Advancement of Emerging Technology Applications for Pharmaceutical Innovation and Modernization
Search the complete list of FDA guidance
Contact FDA
Consumers and general information
Call 1-888-INFO-FDA (1-888-463-6332), or contact the FDA center or office related to your inquiry.
Press
Office of Media Affairs: Email [email protected] or call 301-796-4540
Industry
- For questions related to medical countermeasures, contact [email protected].
- For questions related to biologics, see Manufacturers Assistance and Technical Training Branch (MATTB).
- For questions related to devices, see Device Advice: Comprehensive Regulatory Assistance.
- For questions related to drugs, contact [email protected].