FDA Guidance for Industry: Advanced Manufacturing Technologies Designation Program

Title:
FDA Guidance for Industry: Advanced Manufacturing Technologies Designation Program

https://www.gmp-compliance.org/files/guidemgr/Advanced-Manufacturing-Technologies-Designation-Program.pdf

Origin/Publisher:

FDA

Content:
This 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 (hereinafter designated AMT

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