FDA Guidance for Industry: Immunogenicity-Related Considerations for Low Molecular Weight Heparin
Title:
FDA Guidance for Industry: Immunogenicity-Related Considerations for Low Molecular Weight Heparin
Origin/Publisher:
FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM392194.pdf
Content:
This guidance discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR 19621).