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FDA, FTC Warn 7 Companies About Covid Claims

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FDA and the FTC warn seven companies they are selling unapproved and misbranded drugs containing cannabidiol as Covid-19 treatment...

Announced/Unannounced Inspection Pilot Moves Forward

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ORA Office of Pharmaceutical Quality Operations director Alonza Cruse says FDA is beginning its long-planned pilot program to meas...

FDA Enterprise Data Implementation Roadmap Coming

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FDA commissioner Robert Califf and chief information officer Vid Desai provide an overview of the agencys progress in data and tec...

Teva Recalls 1 Lot of IDArubicin Injection

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FDA says Teva is recalling one lot of its leukemia drug IDArubicin hydrochloride injection due to the presence of particulate matt...

Comments Extended on Carbadox Carcinogenic Concern

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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 inf...

Monitor Thyroid in Some Babies and Children: FDA

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FDA says it is recommending thyroid monitoring for children age 3 and younger who receive iodinated contrast media for imaging stu...

Guilty Plea in Compounded Rx Kickback Scheme

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The Justice Department says a Pennsylvania man pleaded guilty to healthcare fraud and violating the Anti-Kickback Statute in a com...

Shuren, Industry Support MDUFA 5 at Hearing

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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 pro...

Sky Medical New Geko Device Cleared

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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 s...

FDA Cuts Sotrovimab EUA Regions

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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 ...