For the Submission of Chemistry, Manufacturing and Controls and Establishment Description Information for Human Plasma-Derived Biological Products, Animal Plasma or Serum-Derived Products: Guidance for Industry:
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
February 17, 1999
July 15, 2024
84402487-bfa5-4bc3-9edf-4a7c88bac51d
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