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TXT FDA, FTC Warn 7 Companies About Covid Claims [2711 Words] [ Price : $8.95]
FDA and the FTC warn seven companies they are selling unapproved and misbranded drugs containing cannabidiol as Covid-19 treatments.
03/30/2022
 
 
TXT Announced/Unannounced Inspection Pilot Moves Forward [517 Words] [ Price : $8.95]
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
 
 
TXT FDA Enterprise Data Implementation Roadmap Coming [2755 Words] [ Price : $8.95]
FDA commissioner Robert Califf and chief information officer Vid Desai provide an overview of the agency’s progress in data and technology modernization.
03/30/2022
 
 
TXT Teva Recalls 1 Lot of IDArubicin Injection [2645 Words] [ Price : $8.95]
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
 
 
TXT Comments Extended on Carbadox Carcinogenic Concern [73 Words] [ Price : $8.95]
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
 
 
TXT Monitor Thyroid in Some Babies and Children: FDA [2730 Words] [ Price : $8.95]
FDA says it is recommending thyroid monitoring for children age 3 and younger who receive iodinated contrast media for imaging studies.
03/30/2022
 
 
TXT Guilty Plea in Compounded Rx Kickback Scheme [2789 Words] [ Price : $8.95]
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
 
 
TXT Shuren, Industry Support MDUFA 5 at Hearing [999 Words] [ Price : $8.95]
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
 
 
TXT Sky Medical New Geko Device Cleared [210 Words] [ Price : $8.95]
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
 
 
TXT FDA Cuts Sotrovimab EUA Regions [2751 Words] [ Price : $8.95]
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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