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David Kessler Taking Over Covid-19 Vaccine Response

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The incoming Biden Administration chooses former FDA commissioner David Kessler stration to lead the U.S. Covid-19 vaccination eff...

FDA WEBVIEW CLOSED FOR MLK DAY

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FDA Webviews newsroom closes Monday (1/18) in observance of Martin Luther King day.

Indictment on Scheme to Steal Medical Devices for Resale

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FDA announces an indictment (XXX DELETE XXX)charging two former Michigan-based Beaumont Hospital employees and a medical supply di...

Orange Book Modernization Act Codifies Current Practices: Analysis

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Two Hyman Phelps attorneys analyze provisions of the Orange Book Modernization Act signed into law earlier this month.

Covid-19 Coagulation Systems Guidance

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FDA issues a pandemic guidance easing enforcement against some modifications to coagulation systems.

FDA Withdrawing 27 No-longer-marketed ANDAs

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Federal Register notice: FDA withdraws approval of 27 ANDAs from multiple applicants because the products are no longer marketed.

Proposal to Exempt 90 510(k) Devices Due to Covid

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Federal Register notice: FDA seeks comments on a proposal to make permanent certain medical device regulatory flexibilities provid...

FDA Tracking of NDA/ANDA Review Info

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Federal Register notice: HHS requires FDA to publish annually on its Web site certain NDA/ANDA review tracking information.

Canine Idiopathic Epilepsy Drug Approved

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FDA gives conditional approval to Pegasus Laboratories KBroVet-CA1 to treat idiopathic epilepsy in dogs.

Hyperfine Research 510(k) Cleared for Brain Imaging

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FDA clears a Hyperfine Research 510(k) for its deep-learning image analysis software to measure brain structure and pathology in i...