FDA Guidance for Industry: Immunogenicity-Related Considerations for Low Molecular Weight Heparin

Titel:
FDA Guidance for Industry: Immunogenicity-Related Considerations for Low Molecular Weight Heparin
Herkunft/Verlag:

FDA, http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM392194.pdf

Inhalt:
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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR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).

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