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          Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for IndustrySearch for FDA Guidance Documents GUIDANCE DOCUMENT
	Immunogenicity-Related Considerations for Low Molecular Weight Heparin Guidance for Industry
					
		
		February 2016


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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR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

                                                                                  Content current as of:
      08/24/2018
         
                  
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