FDA Guidance for Industry: CMC Postapproval Manufacturing Changes for Specific Biological Products To Be Documented in Annual Reports
Titel:
FDA Guidance for Industry: CMC Postapproval Manufacturing Changes for Specific Biological Products To Be Documented in Annual Reports
Internet:
Herkunft/Verlag:
FDA, https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM570441.pdf
Inhalt:
This guidance provides recommendations to holders of biologics license applications (BLAs) for specified products regarding the types of changes to an approved BLA to be documented in an annual report under 21 CFR 601.12.