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TXT Zhuhai Aofute Medical Technology CGMP Violations [2880 Words] [ Price : $8.95]
FDA warns China’s Zhuhai Aofute Medical Technology Co. about CGMP and other violations in its manufacturing of finished drugs.
01/21/2020
 
 
TXT FDA Launching Drug Risk Management Board [2735 Words] [ Price : $8.95]
CDER launches its Drug Risk Management Board to facilitate rapid analysis and resolution of drug safety issues throughout the Center.
01/21/2020
 
 
TXT Clinical Performance Assessment Guidance [2685 Words] [ Price : $8.95]
FDA publishes a guidance on computer-assisted detection devices applied to radiology images and radiology device data.
01/21/2020
 
 
TXT Latest FDA Warning Letters [734 Words] [ Price : $8.95]
FDA releases its latest batch of Warning Letters that includes CGA Limited, Curewave Lasers, Tismor Health and Wellness, Vevazz and Zhuhai Aofute Medical Tech.
01/21/2020
 
 
TXT FDA Approves Horizon’s Rare Eye Disease Drug [169 Words] [ Price : $8.95]
FDA approves a Horizon Therapeutics BLA for Tepezza (teprotumumab-trbw) for treating adults with thyroid eye disease.
01/21/2020
 
 
TXT GAO on More Drug Development Machine Learning [2676 Words] [ Price : $8.95]
A Government Accountability Office report describes six policy options for overcoming challenges to increasing the use of machine learning in drug development.
01/21/2020
 
 
TXT Office of New Drugs Name Changes [2632 Words] [ Price : $8.95]
CDER says names of the Office of New Drugs offices and divisions were changed as part of its reorganization.
01/21/2020
 
 
TXT Medtronic ‘Smallest’ Pacemaker w/AV Synchrony OK’d [196 Words] [ Price : $8.95]
FDA approves a Medtronic PMA for the Micra AV, which it describes as the world’s smallest pacemaker with atrioventricular synchrony.
01/21/2020
 
 
TXT CGMP Violations at Tismor Health and Wellness [2901 Words] [ Price : $8.95]
FDA warns Australia’s Tismor Health and Wellness about CGMP and other violations in its work as a contract manufacturer of finished drugs.
01/21/2020
 
 
TXT Info Collection on Radioactive Research Committees [74 Words] [ Price : $8.95]
Federal Register notice: FDA seeks comments on an information collection extension for “Radioactive Drug Research Committees—21 CFR 361.1.”
01/21/2020
 
 
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