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FDA Grant to C-Path for Neonate Drug Study

[ Price : $8.95]

FDA awards a multi-year grant to C-Path to advance standards and methodologies designed to generate real-world evidence from real-...

Latest FDA Warning Letters

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FDA releases its latest batch of Warning Letters that include KVK-Tech and Shilpa Medicare Limited.

Abiomeds Cardiopulmonary Bypass Cleared by FDA

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FDA grants Abiomed 510(k) clearance for an all-in-one, compact cardiopulmonary bypass system called the Abiomed Breethe OXY-1 Syst...

CGMP Violations at Indias Shilpa Medicare Limited

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FDA warns Indias Shilpa Medicare Limited about CGMP and field alert reporting violations in its manufacturing of finished drugs.

Guidance on ANDA References to Approved Drug Products

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FDA issues a guidance on how ANDA applicants should accurately refer to a reference-listed drug, reference standard, and the basis...

FDA Delaying AED Accessory Premarket Approval

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FDA says it is delaying until 2/3/2022 enforcement of compliance with PMA requirements for AED accessories.

NIH Ends Lilly Covid Antibody Study

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NIH ends enrollment in a clinical trial of a Lilly investigational monoclonal antibody intended to treat hospitalized Covid-19 pat...

Homeopathic Drug Marketer Can Challenge FDA Policy: Court

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The Washington, DC District Court rules that a recent FDA decision to remove a decades-old compliance policy affecting unapproved ...

Covid Travel Ban Blocks Spectrum Cancer Drug Inspection

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FDA defers a review action on a Spectrum Pharmaceuticals BLA for Rolontis (eflapegrastim) because of a Covid-19-related travel res...

Medtronic PMA OKd for Abre Venous Stent

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FDA approves a Medtronic PMA for its Abre venous self-expanding stent system for use in the iliofemoral veins in patients with out...