Issue Date: February 18, 2016
Issued by: Center for Drug Evaluation and Research
Topic(s): Chemistry, Manufacturing, and Controls (CMC), Pharmaceutical Quality
Status: Final
Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry
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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR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). Section II includes background information. Section IIIA includes recommendations on meeting the requirement for active ingredient sameness for abbreviated new drug applications (ANDAs) for LMWHs, which helps to address immunogenicity-related considerations in the context of ANDAs.
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