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discusses immunogenicity-related considerations for low molecular weight heparin (LMWH) products and finalizes the draft guidance titled Immunogenicity-Related Considerations for the Approval of Low Molecular Weight Heparin for NDAs and ANDAs that was published on April 9, 2014 (79 FR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

Zurück

GMP Seminare nach Thema

Cookies helfen uns bei der Bereitstellung unserer Dienste. Durch die Nutzung unserer Dienste erklären Sie sich damit einverstanden, dass wir Cookies setzen. Weitere Informationen

OK