FDA Guidance for Industry CMC Postapproval Manufacturing Changes to be documented in Annual Reports

Title:
FDA Guidance for Industry CMC Postapproval Manufacturing Changes to be documented in Annual Reports

https://www.gmp-compliance.org/files/guidemgr/UCM217043.pdf

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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