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Biologics

Covid Vaccine Hold Should not Slow Development: Fauci

National Institute of Allergy and Infectious Diseases director Anthony Fauci dismisses any notion that a reported serious adverse reaction associated ...

Medical Devices

FDA Updates Covid MDR Questions, Answers

FDA updates FAQs on submitting adverse events reports for medical devices marketed under emergency use authorizations.

Medical Devices

FDA Promoting Covid Test Development: Shuren

CDRH executives say they encourage and will consider innovative proposals from Covid-19 test developers.

Human Drugs

Nutritional Supplements Corp. Unapproved New Drugs

FDA warns Nutritional Supplements Corp. that it is marketing unapproved and misbranded new drugs.

Medical Devices

Alert on Hot/Cold Therapy Devices

An FDA safety alert warns patients and health care providers about the risk of injury that may happen to patients if the cold-therapy mode on hot/cold...

Medical Devices

Roche BKV Test Cleared by FDA

FDA clears a Roche 510(k) for the cobas BKV Test and its use on the cobas 6800 and 8800 Systems.

Human Drugs

Researchers Caution Hospitals on Drug Industry Money

Researchers say that teaching hospitals that receive non-research payments from drug companies should guard against institutional conflicts of interes...

Medical Devices

FDA OKs Medtronic Intrepid Early Feasibility Study

FDA approves an early feasibility study for Medtronics Intrepid valve replacement system in patients with severe tricuspid regurgitation.

Human Drugs

CGMP Violations at PT MegaSurya Mas

FDA warns Timurs (East Java, Indonesias) PT MegaSurya Mas drug manufacturing facility about CGMP violations in its production of finished pharmaceutic...

Human Drugs

Calvin Scott & Company CGMP Violations

FDA warns Calvin Scott & Company about CGMP violations in its production of finished drugs.