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.
Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
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
Document Type:
Guidance for Industry (Draft)
Content:
Drug Substance: Chemistry, Manufacturing, and Controls Information (Issued 1/2003, Posted 1/28/2003)
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