Guidance for Industry on Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of a guidance for industry entitled "Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality." This guidance was initially published as a draft guidance on February 13, 2012. The draft was revised to clarify FDA's expectations and recommendations and to include references to a recently-developed assay for detecting ruminant contamination of crude heparin.