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Former FDAer Beitz Joins Law Firm

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Hyman, Phelps & McNamara hires former CDER Office of Immunology and Inflammation director Julie Beitz as a principal drug regulato...

FDA Needs to Define Substantial Equivalence

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FDA Webview editor Jim Dickinson urges commissioner Robert Califf to begin rulemaking to establish a regulatory definition of subs...

Ozempic Kidney Study Stopped Due to Efficacy Data

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Positive efficacy data prompts Novo Nordisk to stop a kidney outcomes trial (FLOW) that was studying the effects of Ozempic (semag...

No Care Access Issues in VALOR Trial: Company

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Care Access says an FDA inspection cleared it of good clinical practice violations that had been alleged by Pfizer during its VALO...

Cytoxan Not Withdrawn Over Safety/Efficacy

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Federal Register notice: FDA determines that certain formulations of Baxter Pharmaceuticals Cytoxan (cyclophosphamide) for injecti...

FDA Clears DePuys TriLEAP Plating

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FDA clears a DePuy Synthes 510(k) for the TriLEAP Lower Extremity Anatomic Plating System, a modular, procedure-specific device fo...

Multiple Violations in Abiomed Inspection

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FDA warns Danvers, MA-based Abiomed about Quality System, Medical Device Reporting, and other violations in its marketing of Impel...

2 Unapproved GLP-1 Drug Marketers Warned: FDA

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FDA issues Warning Letters to two online marketers promoting unapproved glucagon-like peptide-1 receptor agonists semaglutide and ...

Suggested Changes to Underrepresented Draft Guide

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Three stakeholder organizations suggest changes to an FDA draft guidance on postmarketing approaches to obtain data on populations...

14 Observations on Spectrum FDA-483

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FDA releases the form FDA-483 with 14 observations from an inspection at the New Brunswick, NJ-based Spectrum Laboratory Products ...