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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

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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

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Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for inv...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

Teleflex Recalls Percutaneous Thrombolytic Device

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Teleflex recalls its Arrow-Trerotola Over-The-Wire Percutaneous Thrombolytic Device Kit, 7FR, after receiving reports about the in...

AstraZeneca, Merck sNDA for Lynparza

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FDA accepts for priority review an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) for the adjuvant treatment of pa...