FDA Finalizes Heparin Guidance; Addresses Industry Comments

The FDA renewed its call for drugmakers to test each incoming shipment of heparin for species origin and contaminants and offered up test methods as part of finalized guidance on the subject. Posted online Tuesday, the guidance includes an assay method for measuring ruminant contamination in crude heparin using real-time polymerase chain reaction as well as an assay for detecting over-sulfated chondroitin sulfate using high-pressure liquid chromatography.
Drug Industry Daily