Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                MCM Issues

MCM Issues

                        Advanced Manufacturing
          Antimicrobial Resistance Information from FDA
          Ebola Preparedness and Response Updates from FDA
          FDA/DoD Collaborations
          FDA Mpox Response
          Medical Countermeasure Monitoring and Assessment
          Pediatric Medical Countermeasures
          Preparedness Information for Consumers
          Radiological and Nuclear Emergency Preparedness Information from FDA
          Smallpox Preparedness and Response Updates from FDA
          Zika Virus Response Updates from FDA Home
          Emergency Preparedness and Response
          Counterterrorism and Emerging Threats
          Medical Countermeasures Initiative (MCMi)
          MCM Issues
          Advanced ManufacturingMCM Issues Advanced Manufacturing
  
  					FDA news, events, and funding opportunities related to advanced manufacturing
	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintImage
              Images representing advanced manufacturing, including 3D-printed products, and manufacturing equipmentOn this page: What's new | What is advanced manufacturing? | Press, statements, and publications | Events | Funding opportunities | Guidance and information for industry | Jobs and internships | Contact FDA

What's new

On **September 26-27, 2023,** FDA and the Product Quality Research Institute (PQRI) will host an FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing. This virtual workshop aims to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice. Registration will open in Summer 2023.
	On **June 8, 2023,**the Duke-Margolis Center for Health Policy, under a cooperative agreement with FDA, will convene a workshop,****Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches, to support the utilization of innovative manufacturing technologies for drugs and biological products. Attendees may join in-person in Washington, DC or virtually. Please register in advance.
	**May 22, 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 new 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.
	**May 10, 2023:**FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing - As with other evolving fields of science and technology, there are challenges associated with AI/ML in drug development, such as ethical and security considerations like improper data sharing or cybersecurity risks. There are also concerns with using algorithms that have a degree of opacity, or algorithms that may have internal operations that are not visible to users or other interested parties. This can lead to amplification of errors or preexisting biases in the data. We aim to prevent and remedy discrimination — including algorithmic discrimination, which occurs when automated systems favor one category of people over other(s) — to advance equity when using AI/ML techniques. To address these concerns, the FDA has released a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (PDF, 1.3 MB). Sumit comments by **August 9, 2023**. To further address the use of AI in drug manufacturing, in February 2023, FDA issued another discussion paper, Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB), as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.
	**May 4, 2023:**FDA updated the Catalog of Regulatory Science Tools to Help Assess New Medical Devices to include a new tool: Additively Manufactured Mock Spine Cage Designs for Mechanical Performance Test Assessments: STL Set 1. The Catalog of Regulatory Science Tools provides a peer-reviewed resource for medical device companies to use where standards and qualified Medical Device Development Tools (MDDTs) do not yet exist. These tools do not replace FDA-recognized standards or MDDTs.

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

**May 22, 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 new 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.
	**May 10, 2023:**FDA Releases Two Discussion Papers to Spur Conversation about Artificial Intelligence and Machine Learning in Drug Development and Manufacturing - As with other evolving fields of science and technology, there are challenges associated with AI/ML in drug development, such as ethical and security considerations like improper data sharing or cybersecurity risks. There are also concerns with using algorithms that have a degree of opacity, or algorithms that may have internal operations that are not visible to users or other interested parties. This can lead to amplification of errors or preexisting biases in the data. We aim to prevent and remedy discrimination — including algorithmic discrimination, which occurs when automated systems favor one category of people over other(s) — to advance equity when using AI/ML techniques. To address these concerns, the FDA has released a discussion paper, Using Artificial Intelligence and Machine Learning in the Development of Drug and Biological Products (PDF, 1.3 MB). Sumit comments by **August 9, 2023**. To further address the use of AI in drug manufacturing, in February 2023, FDA issued another discussion paper, Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB), as part of the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) Initiative.
	**February 14, 2023:**FDA’s Office of Pharmaceutical Quality (OPQ), in the Center for Drug Evaluation and Research (CDER), issued its 2022 Annual Report (PDF, 1.9 MB), which highlights priorities to ensure that quality drugs are available to the American public. OPQ efforts in 2022 included supporting the approval of 3 applications using emerging technologies such as continuous manufacturing.
	**December 19, 2022:** FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology - The White House Office of Science and Technology Policy (OSTP) — in coordination with FDA, EPA, and USDA — announced a request for information related to the Coordinated Framework for the Regulation of Biotechnology; comments close February 3, 2023. This action requests relevant data and information to help identify regulatory ambiguities, gaps, inefficiencies, or uncertainties in the Coordinated Framework for the Regulation of Biotechnology. The request for information seeks case studies and other data that relate to new and emerging biotechnology products. The information provided will help regulatory agencies improve the clarity and efficiency of the regulatory processes for biotechnology products, as described in Executive Order 14081, “Advancing Biomanufacturing and Biotechnology Innovation for a Sustainable, Safe, and Secure Bioeconomy.” OSTP, FDA, EPA, and USDA will hold a virtual listening session on January 12, 2023 (1:00 p.m. ET). To learn how the FDA, EPA, and USDA will work together to implement Executive Order 14081, visit the Unified Website for Biotechnology Regulation.
	OSTP also published a request for information on the National Biotechnology and Biomanufacturing Initiative, seeking public input on how advances in biotechnology and biomanufacturing can help achieve goals that were previously out of reach and what steps can be taken to ensure the U.S. has the right research ecosystem, workforce, data, domestic biomanufacturing capacity, and other components to support a strong bioeconomy. Comments close January 20, 2023.
	**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.More press, statements, and publications
	**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*
	**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.
	**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).
	**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 inputsthat 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 statementincludes 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.
	**F****ebruary 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

**September 26-27, 2023:** FDA/PQRI Workshop on the Regulatory Framework for the Utilization of Artificial Intelligence in Pharmaceutical Manufacturing (virtual) - This workshop, hosted by FDA and the Product Quality Research Institute (PQRI), aims to facilitate interaction among AI stakeholders on critical areas for development, implementation, and regulatory consideration including uses in process development and control, operation of Pharmaceutical Quality Systems, lifecycle approaches, and Current Good Manufacturing Practice. Registration will open in Summer 2023.
	**June 8, 2023:**Advancing the Utilization and Supporting the Implementation of Innovative Manufacturing Approaches (Washington, DC or virtual) - Convened by the Duke-Margolis Center for Health Policy under a cooperative agreement with FDA, to support the utilization of innovative manufacturing technologies for drugs and biological products.
	**June 13-14, 2023:** Registration is open for the 2023 FDA Science Forum. Topic areas for this virtual event include Product Development and Manufacturing, including advanced manufacturing.Previous events
	**March 14, 2023:**FDA CBER Office of Therapeutic Products (OTP) Advanced Manufacturing and Analytical Technologies (AMAT) for Regenerative Medicine Therapies (RMT) Workshop (virtual) - For FDA staff and cell and gene therapy stakeholders to discuss innovative manufacturing technologies and alternative testing methods, and share experiences, challenges, and best practices critical for chemistry, manufacturing, and controls (CMC) of cellular and gene therapies and tissue engineered medical products.  Please registerin advance.
	**January 12, 2023:**Virtual Public Listening Session to Identify Ambiguities, Gaps, and Uncertainties in the Coordinated Framework for the Regulation of Biotechnology (webinar, 1:00 p.m. ET) *Also see: FDA and Federal Partners Issue Request for Information on the Regulation of Biotechnology*
	**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 collaborationbetween 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

**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 (if you missed it, recordings are available, along with a BAA Q&A). For funding consideration in FY 2023, submit white papers by****5:00 p.m. EST, January 23, 2023.Previous funding opportunities
	**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.

	Integrated toolbox for digital design, scale-up, control and optimization of advanced API manufacturing processes – Rutgers University
		Application of smart data analytics for biomanufacturing – Massachusetts Institute of Technology
		Controlled protein capture via continuous crystallization and precipitation for monoclonal antibody manufacturing - – Massachusetts Institute of Technology
		Assessment tools for surveillance and monitoring of real-world data systems and processes to ensure product quality – Purdue University
		Economics and Risks Associated with FDA’s Quality Management Maturity (QMM) Program – University of Maryland
	**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 projects
	America Makes opportunities (challenges, RFPs, etc.)Guidance and information for industry

Recently updated guidance documents specific to advanced manufacturing include:

March 2023:****FDA issued the ICH final guidance, Q13 Continuous Manufacturing of Drug Substances and Drug Products and a discussion paper for stakeholder comment, Discussion Paper: Artificial Intelligence in Drug Manufacturing (PDF, 1.7 MB). These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls. FDA asked interested stakeholders to provide input on certain areas of consideration identified in the discussion paper by May 1, 2023.
	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
	Catalog of Regulatory Science Tools to Help Assess New Medical Devices*Search the complete list of FDA guidance*

Jobs and internships

**December 20, 2022:**The CDRH Office of Science and Engineering Laboratories (OSEL) has several paid and unpaid opportunities for students to engage in OSEL’s Regulatory Science Research Programs, which consist of a variety of research projects primarily focused on laboratory research of medical devices. Research opportunities include advanced and continuous manufacturing projects. Applications will be accepted on a rolling basis through March 2023.For more information and the latest FDA career opportunities, see:

Jobs and Training at FDA
	Scientific Careers at FDA
	Scientific Internships, Fellowships / Trainees and Non-U.S. Citizens
	Title 21: 21st Century Cures Act PositionsContact 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 fdaoma@fda.hhs.gov or call 301-796-4540

Industry

For questions related to medical countermeasures or the OCET Advanced Manufacturing Program, contact AskMCMi@fda.hhs.gov.
	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 CDER-ETT@fda.hhs.gov.

                                                                                  Content current as of:
      06/07/2023
              
              
Topic(s)
			  Research
				    				       				    				       Emergency ResponseMCM Issues

          
                        Advanced Manufacturing
          Antimicrobial Resistance Information from FDA
          Ebola Preparedness and Response Updates from FDA
          FDA/DoD Collaborations
          FDA Mpox Response
          Medical Countermeasure Monitoring and Assessment
          Pediatric Medical Countermeasures
          Preparedness Information for Consumers
          Radiological and Nuclear Emergency Preparedness Information from FDA
          Smallpox Preparedness and Response Updates from FDA
          Zika Virus Response Updates from FDA
 Subscribe
                        Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases, and advanced manufacturing.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop