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FDA Hits Spanish Drug Facility with 483

[ Price : $8.95]

FDA cites Laboratorios Farmaceuticos Rovi in a four-item Form FDA-484 after inspecting the companys Madrid, Spain manufacturing fa...

Device Measuring Neurologic State Cleared

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FDA clears a Forest Devices 510(k) for the SignalNED Model RE System, a device that uses electroencephalogram technology to assess...

Vanda Hits FDA for Rejecting Tradipitant

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Vanda criticizes FDA for failing to approve its NDA for tradipitant to treat gastroparesis.

Panel to Discuss Seasonal and Avian Flu Preparedness

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Federal Register notice: FDA announces a 10/10 Vaccines and Related Biological Products Advisory Committee meeting to discuss and ...

Contaminated Atovaquone Recalled by Bionpharma

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Bionpharma recalls (Class 1) a single Batch (#2310083) of atovaquone oral suspension due to contamination with Cohnella bacteria.

Guide on Clinical Trials With Decentralized Elements

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Federal Register notice: FDA makes available a final guidance entitled Conducting Clinical Trials With Decentralized Elements that...

Braun Medical Expands Infusion Pump Recall

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Braun Medical expands an earlier recall to add lnfusomat Space Infusion System/Large Volume Pump to previous recalled devices due ...

FDA Posts FDA-483s from 2 Indian Companies

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FDA releases the forms FDA-483 with multiple observations from inspections at Granules India Limited and Gland Pharma, both drug m...

Firms Seek Broad Extrapolation for Pediatric IBD Dosing

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Joint comments from three major drug companies about pediatric inflammatory bowel disease drug development question why FDA does n...

Rubio, King Push FDA on Advanced Drug Manufacturing

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Sens. Rubio and King push FDA to quickly finish implementing the Advanced Manufacturing Technologies Designation Program so indust...