Department of Health and Human Services (DHHS)

This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is intended to facilitate the development of drugs, including biological products, manufactured using an AMT that has been designated as such under the program. 

A strong, committed partnership between industry and the federal government is vital when responding to a public health emergency. Through the work of its three programs, PCI partners with industry to strengthen and enhance the nation’s ability to manufacture, distribute, and administer life-saving vaccines and therapeutics during a public health emergency.

Manufacturing USA was created in 2014 to secure U.S. global leadership in advanced manufacturing by connecting people, ideas, and technology. Manufacturing USA institutes convene business competitors, academic institutions, and other stakeholders to test applications of new technology, create new products, reduce cost and risk, and enable the manufacturing workforce with the skills of the future. Key initiatives include Future Manufacturing Supply Chains Manufacturing, Manufacturing Workforce Development, Advanced Manufacturing Technology Leadership, Covid 19 Manufacturing Recovery, and Clean Energy Manufacturing.

The Materials Genome Initiative is a federal multi-agency initiative for discovering, manufacturing, and deploying advanced materials twice as fast and at a fraction of the cost compared to traditional methods. The initiative creates policy, resources, and infrastructure to support U.S. institutions in the adoption of methods for accelerating materials development. 

The Biopharmaceutical Manufacturing Preparedness Consortium (BioMaP-Consortium) supports the Biomedical Advanced Research and Development Authority (BARDA) and is comprised of industry partners across the drug and vaccine manufacturing supply chain, including manufacturers of required raw materials and consumables, developers of innovative manufacturing technologies, and suppliers of fill finish services. This consortium seeks to expand the industrial and manufacturing base for medical countermeasures to include the requisite capabilities, flexibilities, and strategies to secure needed medical supplies to meet the nation’s public health preparedness and response requirements.