Guideline: 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, August 1996
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| Titel: | 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, August 1996 |
| Internet: | https://www.federalregister.gov/articles/1996/10/31/96-27992/guidance-for-industry-for-the-submission-of-chemistry-manufacturing-and-controls-information-for-a |
| Herkunft/Verlag: | Freedom of Information Staff, (HFI 35), Food and Drug Administration, Rm. 12 A - 30, 5600 Fishers Lane, Rockville, MD 20857, USA, http://www.fda.gov/cder/guidance |
| Inhalt: | Leitlinien über Zulassungsanforderungen an best. biotechnologische Produkte |
| Dokumentenart: | FDA Guidance for Industry |
