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510(k) Third Party Review EUA Guidance

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FDA publishes a draft guidance on third-party review of 510(k)s and EUAs.

FDA Issuing Device Electronic Export Documents

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FDA says CDRH has begun issuing several types of electronic export documents for medical devices.

CGMP Violations in Inopak Inspection

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FDA warns Ringwood, NJ-based Inopak about CGMP violations in its production of finished drugs.

Clinical Hold on Iovance Lung Cancer Trial

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FDA places a clinical hold on Iovance Biotherapeutics IOV-LUN-202 clinical trial, which is assessing LN-145 tumor infiltrating lym...

Federal Register Notices from Holiday Break

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FDA Webview summarizes the Federal Register notices published during our holiday break.

Deep Flaws in FDA Device Oversight: KFF Health News

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A KFF Health News report on a year-long investigation into the FDA 510(k) medical device clearance pathway finds significant flaws...

Colonial Dames CGMP Violations

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FDA warns Commerce, CA-based Colonial Dames Company about repeat CGMP violations in its manufacture of misbranded and unapproved d...

QS Violations at Swedens Sonesta Medical

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FDA warns Solna, Sweden-based Sonesta Medical about Quality System violations in its manufacturing of three medical devices.

DHT Remote Data Acquisition Guidance

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FDA publishes a guidance with recommendations on using digital health technologies for remote data acquisition.

Animal MUMS Drug Guidance

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FDA publishes a guidance to assist sponsors in seeking approval of new animal drugs for minor uses or minor species.