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 CMC Postapproval Manufacturing Changes to be documented in Annual Reports
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM217043.pdf
Content:
This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes that may be reported in annual reports
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