Demonstration of Comparability of Human Biological Products, Including Therapeutic Biotechnology-derived Products

Detailed guidance document from FDA and regulatory agencies.

Document Details

Document Type

Guidance Document

Issue Date

March 31, 1996

Office

Center for Drug Evaluation and Research Center for Biologics Evaluation and Research

Document ID

5f3582cf-0b01-4b83-94f5-91049a28d307

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