U.S. flag An official website of the United States government
  1. Home
  2. Emergency Preparedness and Response
  3. Counterterrorism and Emerging Threats
  4. Medical Countermeasures Initiative (MCMi)
  5. MCM Issues
  6. Advanced Manufacturing
  1. MCM Issues

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 | Contact 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

  • 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, 2022Also 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. 



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

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.


Office of Media Affairs: Email fdaoma@fda.hhs.gov or call 301-796-4540



Sign up to receive email alerts on emergency preparedness and response topics from FDA, including medical countermeasures and emerging infectious diseases, and advanced manufacturing.

Back to Top