Draft Guidance for Industry on Heparin for Drug and Medical Device Use; Monitoring Crude Heparin for Quality; Availability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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality.'' This draft guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, and others to the potential risk of crude heparin contamination.