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TXT Latest Federal Register Notices [1394 Words] [ Price : $8.95]
FDA Review posts the Federal Register notice for the week ending 9/18/2020.
09/20/2020
 
 
TXT OPDP Looking at Medical Conference Drug Promotion [2706 Words] [ Price : $8.95]
The CDER Office of Prescription Drug Promotion says it wants to ask medical conference healthcare professional attendees about their experiences at drug company exhibit booths during the conference.
09/17/2020
 
 
TXT FDA Publishes Covid-19 Molecular Test Comparisons [2763 Words] [ Price : $8.95]
FDA publishes a table comparing the performance of over 50 Covid-19 molecular diagnostic tests.
09/17/2020
 
 
TXT Acutus Medical 3D Imaging and Mapping Catheter [139 Words] [ Price : $8.95]
FDA clears a Acutus Medical 510(k) for the second-generation AcQMap 3D imaging and mapping catheter.
09/17/2020
 
 
TXT Historic Data Show Vaccine Approval Risks: Lurie [3033 Words] [ Price : $8.95]
Former FDA associate commissioner Peter Lurie says historic data on vaccine trials should lead to a realistic understanding that some or even all current Covid-19 vaccine candidates may fail.
09/17/2020
 
 
TXT Down Classify Proposal on Cytomegalovirus DNA Assay Devices [116 Words] [ Price : $8.95]
Federal Register notice: FDA proposes to reclassify Class 3 cytomegalovirus deoxyribonucleic acid quantitative assay devices intended for transplant patient management into Class 2.
09/17/2020
 
 
TXT FDA Withdraws Approval of 2 Belviq NDAs Due to Safety [144 Words] [ Price : $8.95]
Federal Register notice: FDA withdraws the approval of two Eisai NDAs for weight loss drugs Belviq tablets and Belviq XR extended-release tablets due to safety concerns.
09/17/2020
 
 
TXT ChemoCentryx NDA Accepted for Avacopan [214 Words] [ Price : $8.95]
FDA accepts for review a ChemoCentryx NDA for avacopan, an orally-administered selective complement 5a receptor inhibitor for treating antineutrophil cytoplasmic antibody (ANCA)-associated vasculitis.
09/17/2020
 
 
TXT 2 Charged in Insys Fentanyl Kickback Scheme [2738 Words] [ Price : $8.95]
Two Florida men are charged as part of an Insys Subsys kickback and bribery scheme.
09/17/2020
 
 
TXT Supplement Market ‘Not Perfectly Regulated’: Tave [2848 Words] [ Price : $8.95]
FDA dietary supplements director Steven Tave tells an industry conference about a regulatory gap between what the law requires and what enforcement can accomplish.
09/17/2020
 
 
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