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QS Violations Found in Westone Labs Inspection

[ Price : $8.95]

FDAs Denver District Office warns Westone Laboratories about QS violations in its manufacturing of the Oto-Ease patient lubricant....

FDA Accepts Geno NDA for Nitric Oxide System

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FDA accepts for review a GeNO LLC NDA for GeNOsyl MVG-2000 Nitric Oxide Delivery System for neonates with hypoxic respiratory fail...

Abbott Moves Promising Hep C Triple Combination Into Phase 3

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Abbott says it is moving into a Phase 3 trial a triple combination of investigational antiviral drugs for treating hepatitis C (HC...

FDA Approves IntelliCell BioSciences New Tissue Facility

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FDA approves the registration of IntelliCell BioSciences new facility in New York, NY to recover, process, package, store, and lab...

FDA Fast Track for Mesothelioma Drug

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FDA grants Morphotek orphan drug status for its investigational cancer drug, amatuximab, for treating malignant pleural mesothelio...

Contract Pharmacal FDA-483 Cites Procedural Violations

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An FDA inspection at Contract Pharmacals Hauppauge, NY drug manufacturing facility cites the firm for not following written produc...

Mixed Vote on Merck OTC Overactive Bladder Patch

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FDAs Nonprescription Drugs Advisory Committee delivers a mixed vote for a Merck proposal to market an over-the counter version of ...

NECC Sister Company Slapped With 20-page FDA-483

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FDA gives the sister company of troubled drug compounder New England Compounding Center a 20-page FDA-483 after a month-long inspe...

FDA Approves Watsons Generic Revatio

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FDA approves a Watson Laboratories ANDA for a generic copy of Pfizers Revatio.

Microgenics FDA-483 Posted for June Inspection

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A June FDA inspection of Microgenics Fremont, CA facility cites the firm for failing to adequately investigate complaints related ...