Biomedical

This draft guidance provides recommendations to persons and organizations interested in participating in FDA’s Advanced Manufacturing Technologies Designation Program, which is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.

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.