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FDA Hits Cutera With Warning on Web Site Promo

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FDA sends Cutera a Warning Letter related to marketing material that appeared on a company owned Web site about uncleared gynecolo...

Medtronic HeartWare Dear Doctor Letter

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A Medtronic Dear Doctor letter describes a potential issue with the driveline cover in its HeartWare Ventricular Assist Device.

Lillys Donanemab Tops Aduhelm in Study

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Lilly says its investigational Alzheimers drug donanemab outperformed Biogens Aduhelm in clearing brain amyloid in a Phase 3 compa...

Innoviva Files NDA for Sul-Dur Antibiotic

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FDA accepts for priority review an Innoviva NDA for intravenous Sul-Dur (sulbactam and durlobactam) for treating infections cause...

Argenx Buys Priority Review Voucher from Bluebird for $102 Mil.

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Argenx pruchases a Priority Review Voucher from Bluebird Bio for $102 million, which Argenx plans to use for a planned BLA for efg...

Act on Orphan Drug Exclusivity: Attorney

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Mayer Brown attorney George OBrien calls on FDA to take steps to respond to a 2021 11th Circuit Court of Appeals decision throwing...

Medical Device Recalls at Two-Year High: Sedgwick

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The Sedgwick second quarter recall index shows that medical device recalls hit a two-year high, while pharmaceutical recalls remai...

9 Observations in Qualgen FDA-483

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FDA releases the form FDA-483 with nine observations from an inspection at the Edmond, OK-based Qualgen outsourcing facility.

Enovis STAR Instrumentation for Ankle Replacement OKd

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FDA approves an Enovis PMA for the STAR Patient Specific Instrumentation and its use with the companys STAR total ankle replacemen...

HHS Delegates Authorities to FDA/NIH for ALS Partnership

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Federal Register notice: HHS delegates to FDA and NIH authorities under the Accelerating Access to Critical Therapies for ALS Act ...