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Recommendations to Improve Medical Supply Chain

[ Price : $8.95]

A National Academies committee recommends seven ways government and other stakeholders can improve the resilience of the U.S. medi...

Pearl 510(k) Cleared for AI X-ray Reader

[ Price : $8.95]

FDA clears a Pearl 510(k) for its Second Opinion, an artificial intelligence radiologic detection aid intended to help dentists id...

Generic Drug Research Focuses on Complex Drugs: Report

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CDER posts its FY 2021 GDUFA Science and Research Report that updates stakeholders on the development of innovative methodologies ...

FDA Wants Quality Metrics Comments

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FDA asks stakeholders to comment on proposed changes to the drug quality metrics reporting program that has been tested in two pil...

Axeda Cybersecurity Vulnerability Found

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FDA says the computer software company PTC is recommending actions to be taken by medical device manufacturers who use PTCs Axeda ...

Court Order Against Salud Natural Entrepreneur

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An Illinois federal court approves a permanent injunction against Waukegan, IL-based dietary supplement maker Salud Natural Entrep...

Mallinckrodt Pays $260 Million on False Claims Violations

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Mallinckrodt agrees to pay $260 million to resolve allegations that it violated the False Claims Act by knowingly underpaying Medi...

FDA Denies 2013 Anticholinergic Label Petition

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FDA denies a petition seeking a stronger Warning on labeling of OTC drugs with anticholinergic effects.

3 More Comments on RWD Draft Guidance

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Three more drug companies comment on an FDA draft guidance on using real-world evidence and data in regulatory decision-making for...

Revance Re-files BLA for DaxibotulinumtoxinA

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Revance Therapeutics refiles its BLA for DaxibotulinumtoxinA for Injection, indicated for treating moderate to severe glabellar li...