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Guide on Device Software Submissions

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Content of Premarket Submissions for Device Software Functi...

All Companies Stopping Isoxsuprine Distribution

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FDA says all manufacturers and labelers of isoxsuprine HCl products have agreed to cease distribution of them.

FDA Patient Cybersecurity Best Practices Video

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FDA launches a video to help patients keep their medical devices safe from cybersecurity attacks.

3 Observations in Atlas Pharmaceuticals FDA-483

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FDA releases an FDA-483 with three observations from an inspection at the Atlas Pharmaceuticals outsourcing facility in Phoenix, A...

Flume Balloon Urinary Catheter Cleared

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FDA clears a Flume Catheter Co. 510(k) for its Flume urinary balloon catheter.

Woodcock Sets High Priority for OTC Covid Tests

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FDA acting commissioner Janet Woodcock testifies before Congress about an agency priority to increase the availability of over-the...

FDA Updates Hill on Covid Therapies, Inspections

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FDA testimony at a Senate hearing on Covid-19 discusses the unprecedented number of new product submissions to fight the disease a...

Diabetes Treatment Goal Can Cause Problems: Reuters

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A Reuters series documents the role diabetes drug marketing techniques played in a significant increase in cases of hypoglycemia a...

FDA Fast Track for TransThera Drug

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FDA grants fast track designation to TransThera Sciences experimental Phase 2 cholangiocarcinoma drug.

10-item FDA-483 to Innoveix Pharmaceuticals

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An FDA inspection leads to a 10-item Form FDA-483 issued to Innoveix Pharmaceuticals that took issue with the firms GMPs for steri...