Guidance for Industry for the Submission of Chemistry, Manufacturing, and Controls Information for a Therapeutic Recombinant DNA-Derived Product or a Monoclonal Antibody Product for In Vivo Use
Detailed guidance document from FDA and regulatory agencies.
Document Details
Guidance Document
August 1, 1996
July 26, 2024
1c78a87a-d482-4f5d-9d0e-b273649f563f
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