FDA发布低分子量肝素免疫原性相关考虑最终指南
Immunogenicity-Related Considerations for Low Molecular Weight Heparin
FDA发布最终指南《低分子量肝素免疫原性相关考虑》，将2014年4月9日发布的同名草案定稿。指南第II节为背景信息，第IIIA节就简化新药申请（ANDA）中低分子量肝素活性成分同一性的要求给出建议。相关意见可通过案卷编号FDA-2013-S-0610提交。
该文件将2014年草案定稿为正式指南，并给出LMWH仿制药申请中活性成分同一性的相关建议。
GUIDANCE DOCUMENT
Final
- Issued by:
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Guidance Issuing Office
Center for Drug Evaluation and Research
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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR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.
Submit Comments
Submit comments on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.
来源：FDA Pharmaceutical Quality Documents · fda.gov