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TXT Draft Guide on Blood Bacterial Rick Controls [129 Words] [ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled “Bacterial Risk Control Strategies for Blood Collection Establishments and Transfusion Services to Enhance the Safety and Availability of Platelets for Transfusion; Draft Guidance for Industry.”
12/06/2018
 
 
TXT FDA Clears Meridian Congenital Cytomegalovirus Assay [87 Words] [ Price : $8.95]
FDA clears a Meridian Bioscience 510(k) for its new Alethia CMV Molecular Amplification Test.
12/06/2018
 
 
TXT Info Collection Extension for Environmental Impact Considerations [49 Words] [ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension entitled “Environmental Impact Considerations.”
12/06/2018
 
 
TXT FDA’s New Real-World Evidence Strategic Framework [2810 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb announces release of a strategic framework for advancing use of real-world evidence in 2019.
12/06/2018
 
 
TXT Medtronic Ventilator Field Correction is Class 1 [2667 Words] [ Price : $8.95]
FDA says a Medtronic field corrective action for its Puritan Bennett 980 ventilator series is a Class 1 recall.
12/06/2018
 
 
TXT In Vitro Companion Device Labeling Guidance [2800 Words] [ Price : $8.95]
FDA issues a guidance on class labeling for companion diagnostic products for classes of oncology therapeutic products.
12/06/2018
 
 
TXT Mylan Expanding Valsartan Recall [2634 Words] [ Price : $8.95]
FDA says Mylan expands its recall of several types of valsartan-containing products.
12/06/2018
 
 
TXT FDA New Approach to Regulating In Vitro Tests [2890 Words] [ Price : $8.95]
FDA commissioner Scott Gottlieb and other agency leaders call for a new unified approach to regulation of in vitro clinical tests.
12/06/2018
 
 
TXT POPS! Blood Glucose Monitoring Device [81 Words] [ Price : $8.95]
FDA clears a POPS! Diabetes Care 510(k) for its POPS! one Blood Glucose Monitoring system.
12/06/2018
 
 
TXT Tris Pharma Recalls Infant Ibuprofen [1185 Words] [ Price : $8.95]
Tris Pharma recalls three lots of infant ibuprofen concentrated oral suspension (50 mg per 1.25 mL) due to the potential for the product higher concentrations of ibuprofen than labeled.
12/06/2018
 
 
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