2021 FDA Science Forum
Fostering Advanced Manufacturing Technologies and Processes to Bolster Supply Chain Resilience and Encourage Continuous Improvement
- Authors:
- Center:
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Contributing OfficeOffice of the Commissioner
Abstract
Background
As part of this mission, FDA must prepare to review and inspect new and innovative technologies used in the production, testing, and monitoring of regulated products. The FDA leverages the scientific expertise of its personnel to develop and assess advanced manufacturing technologies and analytic tools. Advanced Manufacturing has risen to the forefront as a way to build long term capacity for pandemic response and resilience.
Purpose
The Advanced Manufacturing (Adv Mfg) program in the Office of Counterterrorism and Emerging Threats (OCET) is focused on fostering the use of Adv Mfg to:
- improve supply chain resilience to disruption
- increase domestic production of critical medical products
- build flexible capacity to respond to spikes in demand
Expected benefits for Agency include:
- Internal and external grants and projects directed toward Agency priorities
- Increase cross-center cooperation and communication
- Supplement Center innovation and emerging technology efforts
- Assist FDA in development of evaluation metrics and protocols for new/emerging technologies
Discussion
Many methods have been identified as potential avenues to respond to the public health gaps exposed by the pandemic. Adv Mfg is an area where pandemic response and general improvements to the quality of medical products intersect. The OCET Adv Mfg program will:
- help sustain interdisciplinary support for FDA research
- increase FDA engagement with public-private partnerships focused on the development/transition of innovative new tools, technologies, and platforms for Adv Mfg
- enhance internal FDA-wide cross-scientific, multi-disciplinary, exchange of information to inform cross-cutting decisions
