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Dong Debarred Over Stimulants in Supplements

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Federal Register: FDA debars Zhang Xiao Dong for five years from importing articles of food (including dietary supplements) or off...

Jodoin Debarred Over Importing Controlled Drug

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Federal Register notice: FDA debars Robert Richard Jodoin for five years from importing any drug into the U.S. after being convict...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that includes Cipla Limited, Gojo Industries and Windlas Healthcare Private Limit...

Novo Nordisk Halts 3 Hemophilia Trials Over Safety

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Novo Nordisk stops two clinical trials in its concizumab Phase 3 development program and one clinical trial in the Phase 2 program...

FDA Updates Coronavirus Test FAQs

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FDA adds three questions to its FAQs on developing Covid-19 diagnostics.

SGLT2 Inhibitor Safety Label Changes

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FDA approves safety labeling changes for four SGLT2 inhibitors to recommend that their use be temporarily discontinued several day...

Guide on Slowly Progressive, Low-Prevalence Rare Diseases

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Federal Register notice: FDA makes available a final guidance on drugs for slowly progressive, low-prevalence rare diseases with s...

Comments Extended on Homeopathic Drug Guide

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Federal Register notice: FDA extends the comment period on a draft guidance entitled Drug Products Labeled as Homeopathic.

Competitive Generic Therapies Guidance

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Federal Register notice: FDA makes available a final guidance entitled Competitive Generic Therapies.

Coronavirus Testing Improving This Week: Gottlieb

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Former FDA commissioner Scott Gottlieb says that with new approved testing coming online the U.S. will be in good shape for corona...