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FDA Bans 19 Ingredients in OTC Antiseptic Wash Products

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FDA issues a final rule that bans 19 active ingredients including most commonly triclosan and triclocarban from use in over-the-...

Fast Track Granted for Biogen Alzheimers Drug

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FDA grants Biogen fast track status for aducanumab, an investigational treatment for early Alzheimers disease.

Ariad NDA Filed for Brigatinib in Lung Cancer Patients

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Ariad Pharmaceuticals completes a rolling NDA submission for its investigational anaplastic lymphoma kinase (ALK) inhibitor, briga...

Industry, FDA Agree on New Generic User Fees

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Stakeholders praise an agreement with FDA to extend the Generic Drug User Fee Act program for another five years.

FDA Fast Track for Cynapsus Parkinsons Diesease

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FDA grants Cynapsus Therapeutics a fast track designation for APL-130277, a product candidate for treating off episodes in patient...

Steps When a Clinical Trial Primary Outcome Fails

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Researchers list in the New England Journal of Medicine steps researchers can take to try to reduce having a clinical trial primar...

Baxter Tells FDA of Vascu-Guard Issues

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FDA warns healthcare providers about risks associated with using the Baxter Vascu-Guard patch in carotid endarterectomy procedures...

Consumers Concerned About DTC Ads

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Thirteen patient and consumer health advocacy organizations question the wisdom of allowing companies to market regulated products...

New Home for Drug Safety Labeling Changes

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FDA moves drug safety labeling changes to a CDER database to speed publication of the data.

CDRH Guide on 510(k) for Solid State X-ray Devices

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CDRH posts a guidance on Submission of 510(k)s for Solid State X-ray Imaging Devices that outlines the type of data to establish t...