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Zdrowie i gospodarka · 9.07.2015

Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Heparin-Containing Medical Devices and Combination Products: Recommendations for Labeling and Safety Testing." This draft guidance describes FDA's intent to address the safety concerns by clarifying new expectations for labeling with regard to the soon-to-be revised heparin United States Pharmacopeia (USP) monographs as well as outline safety testing recommendations. This draft guidance is not final nor is it in effect at this time.

Source: Federal Register — Food and Drug AdministrationOpen original release →