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FDA Updates Guidance on Pyrogen and Endotoxin Testing

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FDA posts an updated version of its guidance on pyrogen and endotoxin testing, offering manufacturers of drugs, biologics, and med...

FDA Warns of Potentially High-Risk Issue With Insulet Insulin Pumps

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FDA issues an early alert regarding a potentially serious defect in certain insulin pump components manufactured by Insulet.

Oralabs Cited for CGMP Violations

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FDA warns Parker, CO-based Oralabs about CGMP violations in its work as a contract drug manufacturer.

API Deviations Seen in Flowchem Pharma Inspection

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FDA warns Indias Flowchem Pharma about significant CGMP deviations in its production of active pharmaceutical ingredients.

BioMarin Halts Dosing in Some Voxzogo Mid-Stage Trials

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BioMarin says it is discontinuing dosing and enrollment in portions of its mid-stage clinical program for Voxzogo (vosoritide) aft...

Integra Neurosurgical Kits Recalled Over Corrosion Risk

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Integra LifeSciences recalls certain neurosurgical monitoring kits, citing potential safety risks linked to a needle component use...

Quality Control, Microbial Risks Flagged at API Manufacturer

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FDA sends Japanese active pharmaceutical ingredient maker Alps Pharmaceutical a Form 483 from an inspection that identified multip...

Praise for FDA Bayesian Methodology Draft Guidance

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Four stakeholders praise an FDA draft guidance on using Bayesian methods in clinical trial design and suggest ways to improve the ...

FDA Draft Guidance on Responses to FDA-483s Explained

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Two Akin attorneys review a 3/9 FDA draft guidance recommending ways in which it would like to see human and drug manufacturers re...

FDA Rejects Aldeyras Dry Eye Drug Reproxalap

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FDA sends Aldeyra a complete response letter for its investigational dry eye treatment reproxalap, concluding that the company fai...