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Welcome to FDAweb Pay Per View Search our 66,139 - story database FREE   Free Items  Warning Letters  FDA Notices  FDA Calendar    FDA Whistleblowers            1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 Next >>   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     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     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     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     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     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     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     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     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     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       1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20  Next >>

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