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Device Measuring Neurologic State Cleared

[ Price : $8.95]

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

Integrating Trials into Clinical Practice Guide

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Federal Register notice: FDA makes available a draft guidance entitled Integrating Randomized Controlled Trials for Drug and Biolo...

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...

ICER Questions Diversity Action Plan Goal

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The Institute for Clinical and Economic Review asks FDA to reconsider the implications of its stated goal in a draft guidance on c...

FDA OKs Keytruda Pleural Mesothelioma Indication

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FDA approves an additional indication for Mercks Keytruda with chemotherapy to treat unresectable advanced or metastatic malignant...

Bill Introduced on Generic Drug Prompt Approvals

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Congresswoman Nanette Barragn (D-CA) reintroduces the Prompt Approval of Safe Generic Drugs Act, legislation that would remove hur...