💊Exclusive License for Zika Virus Therapy by NIH and Advocate Aurora
The National Institute of Allergy and Infectious Diseases, an institute of the National Institutes of Health, Department of Health and Human Services, Department of Health and Human Services, is contemplating the grant of an exclusive patent license to Advocate Aurora Research Institute, located in Milwaukee, Wisconsin, to practice the inventions embodied in the patent applications listed in the Supplementary Information section of this notice.
Learn More🧪FDA Classifies Zika Virus Serological Reagents to Class II
The Food and Drug Administration (FDA, Agency, or we) is classifying the Zika virus serological reagents into class II (special controls). The special controls that apply to the device type are identified in this order and will be part of the codified language for the Zika virus serological reagents' classification. We are taking this action because we have determined that classifying the device into class II (special controls) will provide a reasonable assurance of safety and effectiveness of the device. We believe this action will also enhance patients' access to beneficial innovative devices in part by reducing regulatory burdens.
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