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FDA Updates Covid MDR Questions, Answers

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

FDA Promoting Covid Test Development: Shuren

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

Nutritional Supplements Corp. Unapproved New Drugs

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

Alert on Hot/Cold Therapy Devices

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An FDA safety alert warns patients and health care providers about the risk of injury that may happen to patients if the cold-ther...

Roche BKV Test Cleared by FDA

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

Researchers Caution Hospitals on Drug Industry Money

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

FDA OKs Medtronic Intrepid Early Feasibility Study

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

CGMP Violations at PT MegaSurya Mas

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

Calvin Scott & Company CGMP Violations

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

Public Meeting on Device User Fee Reauthorization

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