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Guideline

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.

Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
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:Format and Content of the Chemistry, Manufacturing and Controls Section of an Application
Status:withdrawn
Document Type:FDA Guidance for Industry