FDA Issues New Guidance Document on Labeling of Heparin Devices
The Food and Drug Administration on Sept. 20 issued a guidance document outlining “new expectations” for labeling of heparin-containing medical devices and combination products. Coming in response to a spate of heparin product overdose areas caused in part by expressions…
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of drug strength on labels, FDA’s new guidance “addresses those safety concerns” by incorporating recent changes to United States Pharmacopeia drug substance monographs for Heparin Sodium, as well as drug product monographs for Heparin Lock Flush Solution and Heparin Sodium Injection. The new guidance also includes safety testing recommendations.