FDA Related News

Human Drugs

FDA Lifts Entolimod Clinical Hold

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

Medical Devices

FDA Updates Cybersecurity Information

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

Medical Devices

FDA Monitoring NuVasive Device Concerns

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

Human Drugs

Immunexpress Rapid Sepsis Diagnostic Cleared

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

Biologics

FDA Puts Clinical Hold on Ocugen Covid Vaccine

FDA issues a clinical hold for undisclosed reasons on an Ocugen IND intended to evaluate the companys Covid-19 vaccine candidate, BBV152, which is kno...

Concerns About FDA Drug/Device Reclassifications Aired

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

Medical Devices

QS Violations at Invacare Facilities

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

Suggestions for Investigator Safety Reporting Guidance

Two stakeholders make suggestions for changes to an FDA draft guidance on investigator responsibility for safety reporting for investigational drugs a...

Human Drugs

Panel Mixed Vote on Mercks Covid Drug

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

Human Drugs

Teleflex Recalls Percutaneous Thrombolytic Device

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