FDA Inspections of Licensed Biological Thearpeutic Drug products

Title:
FDA Inspections of Licensed Biological Thearpeutic Drug products

https://www.gmp-compliance.org/files/guidemgr/Inspections of Licensed Biological Drug Products 7356_002M.pdf

Origin/Publisher:

FDA

Document Type:
COMPLIANCE PROGRAM GUIDANCE MANUAL
Content:
This program covers both specified and non-specified therapeutic biological drug products now regulated by CDER, but formerly regulated by CBER under this same program.

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