CMC指导原则列表.docx

Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm Below is a sortable table of Chemistry, Manufacturing and Controls (CMC) Guidances:-  HYPERLINK /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm Category ?? HYPERLINK /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm Title ?? HYPERLINK /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm Type ?? HYPERLINK /Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm064979.htm Date ??Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM122858.pdf \t _self Analytical Procedures and Methods Validation?(PDF - 91KB)1 Draft Guidance 08/30/00 Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM192750.pdf \t _self Assay Development for Immunogenicity Testing of Therapeutic Proteins?(PDF - 161KB)2 Draft Guidance 12/04/09 Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM070491.pdf \t _self Botanical Drug Products?(PDF - 437KB)3 Final Guidance 06/01/04 Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM124805.pdf \t _self Changes to an Approved Application for Specified Biotechnology and Specified Synthetic Biological Products?(PDF - 33KB)4 Final Guidance 07/01/97 Chemistry, Manufacturing, and Controls (CMC); Modernization Act  HYPERLINK /downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM077097.pdf \t _self Changes to an Approved NDA or ANDA?(PDF - 108KB)5 Final Guidance 04/01/04 Chemistry, Manufacturing, and Controls (CMC)  HYPERLINK /downloads/Drug