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FDA Guidance for Industry For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma- Derived Biological Products, Animal Plasma or Serum-Derived Products


Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, ,

Document Type:
Guidance for Industry
This document provides guidance on the content and format of the Chemistry, Manufacturing and Controls (CMC) section and the Establishment Description section of a Biologics License Application for a Human Plasma-Derived Biological Product, Animal Plasma or Serum-Derived Product.

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