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FDA Lifts Entolimod Clinical Hold

[ Price : $8.95]

FDA lifts its clinical hold on Statera Biopharmas entolimod for treating acute radiation syndrome.

FDA Updates Cybersecurity Information

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FDA adds four items to its online medical device cybersecurity page.

FDA Monitoring NuVasive Device Concerns

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FDA says the benefits of NuInvasive titanium-based Precice devices continue to outweigh the known risks with updated labeling in p...

Immunexpress Rapid Sepsis Diagnostic Cleared

[ Price : $8.95]

FDA clears an Immunexpress 510(k) for its SeptiCyte Rapid, a diagnostic aid for use in differentiating sepsis from infection-negat...

FDA Puts Clinical Hold on Ocugen Covid Vaccine

[ Price : $8.95]

FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the companys Covid-19 vaccine candidate, ...

Concerns About FDA Drug/Device Reclassifications Aired

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Stakeholders express concerns about an FDA decision in response to an appeals court ruling to reclassify some drugs as drug-led co...

QS Violations at Invacare Facilities

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FDA warns Invacare about QS violations found in inspections at three of its oxygen concentrator manufacturing facilities.

Suggestions for Investigator Safety Reporting Guidance

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Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for inv...

Panel Mixed Vote on Mercks Covid Drug

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FDAs Antimicrobial Drugs Advisory Committee narrowly votes 13-10 to recommend an emergency use authorization for Mercks oral antiv...

Attorneys See Questions in LDT Policy Change

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Three Hyman, Phelps attorneys say an HHS announcement withdrawing a Trump administration policy on FDA review of laboratory-develo...