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Advanced Manufacturing

FDA news, events, and funding opportunities related to advanced manufacturing

Images representing advanced manufacturing, including 3D-printed products, and manufacturing equipment

On this page: What's newWhat is advanced manufacturing?Press, statements, and publications | EventsFunding opportunitiesGuidance and information for industry | Jobs and internshipsContact FDA

What's new

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.




    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


    Other funding

    Guidance and information for industry

    Recently updated guidance documents specific to advanced manufacturing include:

    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:

    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.


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