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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.

Federal Register

Public Meeting on Device User Fee Reauthorization

Federal Register notice: FDA announces a 10/27 virtual public meeting to discuss proposed recommendations for reauthorizing the medical device user fe...

Human Drugs

Guidance on Impaired Renal Function Pharmacokinetics

FDA makes availabile a revised draft guidance on Pharmacokinetics in Patients with Impaired Renal Function Study Design, Data Analysis, and Impact on...

Biologics

Vaccine Companies Pledge Scientific, Ethical Rigor

In a move to shore-up public confidence, nine companies developing Covid-19 vaccines have pledged to uphold scientific, regulatory and ethical rigor a...

Human Drugs

Consistent Hedgehog Inhibitor Labeling Sought

A Duke Medical School dermatology professor calls on FDA to require consistent safety labeling for all approved hedgehog inhibitors.