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Changes Asked in Real-World Evidence Guidance

[ Price : $8.95]

Stakeholders suggest improvements to an FDA draft guidance on using real-world evidence in medical device regulatory decisions.

Viracor-IBT Distributing Unapproved Zika Tests: FDA

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FDA says Viracor-IBT Laboratories is selling unapproved Zika tests.

Concerns Raised About UDI Draft Guidance

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Stakeholders air concerns about an FDA draft guidance on UDI label components.

Eteplirsen Worrisome Model for Drug Approval: Authors

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Two Harvard Medical School professors question the process FDA used to approve a new Duchenne muscular dystrophy drug.

Stakeholders Ask High Court Apotex Hearing

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Fish & Richardson attorneys review two amicus briefs urging the Supreme Court to hear Apotex biologics law appeal against Amgen an...

FDA Seeks OMB Approval for DTC Study

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Federal Register Notice: FDA seeks comments on a planned direct-to-consumer (DTC) advertising study that has been submitted to OMB...

Workshop Planned for Improving Hospital Device Surveillance

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Federal Register Notice: FDA announces a 12/5 public workshop on The Role of Hospitals in Modernizing Evidence Generation for Devi...

CGMP Violations at Czech Interpharm

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FDA warns the Czech Republics Interpharm about CGMP deviations and violations in its production of active pharmaceutical ingredien...

CGMP Violations at Teva Godollo, Hungary, Plant

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FDA warns Teva about CGMP violations at its Godollo, Hungary, finished pharmaceuticals plant.

Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Buderer Drug Company, Colabs International, Diamond Wipes International, ITW PRO...