Format and Content of the Chemistry, Manufacturing and Controls Section of an Application

Title:
Format and Content of the Chemistry, Manufacturing and Controls Section of an Application

https://www.gmp-compliance.org/files/guidemgr/old030fn.pdf

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

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