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Announced/Unannounced Inspection Pilot Moves Forward
[517 Words]
[ Price : $8.95]
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ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is beginning its long-planned pilot program to measure the impact of announced versus unannounced GMP inspections for both domestic and foreign inspections. |
03/30/2022
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Teva Recalls 1 Lot of IDArubicin Injection
[2645 Words]
[ Price : $8.95]
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FDA says Teva is recalling one lot of its leukemia drug IDArubicin hydrochloride injection due to the presence of particulate matter found in one vial by a company inspection. |
03/30/2022
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Comments Extended on Carbadox Carcinogenic Concern
[73 Words]
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Federal Register notice: FDA extends the comment period of a 1/13 Federal Register notice seeking input on scientific data and information related to the residue of carcinogenic concern for the new animal drug carbadox. |
03/30/2022
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Guilty Plea in Compounded Rx Kickback Scheme
[2789 Words]
[ Price : $8.95]
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The Justice Department says a Pennsylvania man pleaded guilty to healthcare fraud and violating the Anti-Kickback Statute in a compounded medication scheme. |
03/30/2022
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Shuren, Industry Support MDUFA 5 at Hearing
[999 Words]
[ Price : $8.95]
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CDRH director Jeff Shuren testifies on Capitol Hill that despite the Covid-19 strain on resources, the medical device user fee program’s track record continues to support an increasing number of device innovators bringing their devices to the U.S. first and a more robust pipeline of innovative new devices. |
03/30/2022
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Sky Medical New Geko Device Cleared
[210 Words]
[ Price : $8.95]
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FDA clears a Sky Medical Technology 510(k) for its new (W3) geko device for increasing microcirculatory blood flow in lower limb soft tissue of patients with venous insufficiency or ischemia. |
03/30/2022
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FDA Cuts Sotrovimab EUA Regions
[2751 Words]
[ Price : $8.95]
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FDA says sotrovimab is no longer authorized in three additional HHS regions where the proportion of Covid-19 omicron BA.2 variant cases is above 50% because the variant is not susceptible to this treatment. |
03/30/2022
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