The Centers of Excellence Initiative

Support our efforts to become an FDA-designated National Center of Excellence by
providing your valuable input at the upcoming meetings.

Background

Advanced and continuous manufacturing has become a growing priority in the FDA’s agenda to improve quality, safety, and access since the early 2000’s. Many companies have succeeded in implementing these technologies and getting products approved. The need to build a strong supply chain has also become a matter of national urgency. In December 2022, President Biden signed into law a congressional bill requiring the
FDA to designate up to five national Centers of Excellence in Advanced and Continuous Manufacturing (HR 4369). The new law also authorized $100M in funding for the FY23-27
period.

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