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Surge in Product Recalls Predicted

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International business management consultancy Sedgwick says drug and medical device product recalls are likely to surge as compani...

Congress Should Ensure FDA Test Review Authority: Pew

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The Pew Trusts calls for legislative action to maintain FDA authority over laboratory-developed tests.

2 Verapamil Drugs Not Withdrawn Due to Safety/Efficacy: FDA

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Federal Register notice: FDA determines that Adams Technologies Isoptin (verapamil hydrochloride) tablets (40mg, 80mg and 120mg) a...

Woodcocks Ideas to Strengthen Clinical Trials

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FDA acting commissioner Janet Woodcock suggests changes to the nations clinical trial system in response to pandemic lessons learn...

Bio-Botanica/Natures Answer Cesium Chloride Product Adulterated: FDA

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FDA warns Bio-Botanica/Natures Answer that it is marketing adulterated Coral Calcium because it contains cesium chloride, an unapp...

Covid Trial Impact Less in Oncology: Study

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Researchers say oncology trials were not affected by the pandemic as much as non-oncology trials.

5 FDA Information Collections Approved by OMB

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Federal Register notice: FDA posts a list of five information collections that have been approved by the Office of Management and ...

FDA Says NeuroHydrate Selling Unapproved New Drug

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FDA warns NeuroHydrate that it is marketing an unapproved new drug.

Reportable Essure Events Posted

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FDA and Bayer post their latest Essure adverse event reports.

FDA Lifts Hold on Regenerons Odronextamab Trials

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FDA lifts a clinical hold on Regeneron and its odronextamab monotherapy trials in patients with follicular lymphoma and diffuse la...