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Class 1 Recall of Medtronic Insulin Pumps

[ Price : $8.95]

FDA classifies as Class 1 a Medtronic recall of certain insulin pumps that was initiated to replace any pump that has a clear reta...

Former FDAer Leading Agilis Consulting

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Agilis Consulting names former FDA human factors team leader Shannon Hoste as president.

FDA Study Shows Path to Uninterrupted Drug Supply

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An FDA/HHS-funded University of Maryland study identifies factors that it says can lead to an uninterrupted supply of drugs for th...

J&J Seeks EUA for Booster Jab

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Johnson & Johnson files data to support an emergency use authorization for its Covid-19 booster shot in those 18 years of age and ...

4 Device De Novo Guidances Revised

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FDA revises four guidance documents based on a final rule on the medical device de novo classification process.

AZ Wants EUA for Covid Prophylaxis Drug

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AstraZeneca applies for an FDA emergency use authorization for a long-acting antibody combination as a Covid-19 prophylaxis.

Medtronic Expands Class 1 Remote Controller Recall

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FDA says Medtronic has expanded its recall of insulin pump remote controllers due to cybersecurity risks.

FDA Promoting Advanced and Smart Manufacturing

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FDA releases a report calling for accelerating the adoption of advanced and smart manufacturing technologies.

Notice Withdrawn on Review Voucher Issued in Error

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Federal Register notice: FDA withdraws a 9/30 notice that announced in error the issuance of a priority review voucher to a rare p...

Updated Covid-19 Guidance Listing Available

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Federal Register notice: FDA updates its listing of available guidance documents related to the Covid-19 public health emergency.