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FDA Warns Overseas OTC Manufacturers

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FDA warns six overseas manufacturers of over-the-counter drugs about CGMP violations.

CBER Allowing Device In-Person Meetings

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CBER begins a phased implementation of in-person industry meetings with device manufacturers.

BIO Supports FDAs AI/ML Discussion

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The Biotechnology Innovation Organization says it supports FDA efforts to promote stakeholder discussion on the role of artificial...

Wegovy Hits Trial MACE Goal

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Novo Nordisk says its Wegovy cut the risk of major adverse cardiovascular events by 20% in overweight or obese adults in the SELEC...

FDA OKs Boston Scientific Cryoablation Device

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FDA approves a Boston Scientific PMA for the POLARx Cryoablation System for treating patients with paroxysmal atrial fibrillation.

Sage Postpartum Depression Oral Drug Approved

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FDA approves a Sage Therapeutics NDA for Zurzuvae (zuranolone), an oral drug for treating postpartum depression in adults.

Draft Guide on Cosmetic Registration/Listing

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FDA issues a draft guidance entitled Registration and Listing of Cosmetic Product Facilities and Products: Guidance for Industry. ...

Astellas Eye Drug Approved by FDA

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FDA approves an Astellas Pharmas Izervay (avacincaptad pegol intravitreal solution) for treating geographic atrophy secondary to a...

FDA Clears Abbotts Hematology Device

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FDA clears an Abbott 510(k)for its Alinity h-series hematology system for use by laboratories to run complete blood counts.

Cubicin Not Withdrawn Due to Safety/Efficacy

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Federal Register notice: FDA determines that Cubist Pharmaceuticals Cubicin and Cubicin RF (daptomycin) powder for injection were ...