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The following guideline can be ordered through the address listed in the "Source/Publisher"-category.
In cases in which you can order through the Internet we have established a hyperlink.
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| 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 |
| Origin/Publisher: | 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 |
| Content: | Guidelines about registration requirements for certain biotechnology products. |
| Document Type: | FDA guidance for industry |
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