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.
FDA Guidance for Industry: ANDA's: Impurities in Drug Substances
Internet:
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/ , http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM172002.pdf
Document Type:
Guidance for Industry
Content:
This guidance provides recommendations for information in ANDAs and supporting DMFs on the identification and qualification of impurities in drug subtances.
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