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Ranitidine Products May Return to Market: FDA

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FDA says it may approve returning ranitidine-containing products to the market based on new CDER research into the carcinogen NDMA...

AnazaoHealth Compounding Unapproved Drugs: FDA

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FDA warns AnazaoHealth that it is compounding drugs that do not meet legal requirements and are considered to be misbranded unappr...

Astellas Pauses ASPIRO Trial

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Astellas pauses screening and dosing additional participants in its ASPIRO trial of an investigational gene therapy.

Woodcock Attempts to Quell CBER Dissent

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FDA acting commissioner Janet Woodcock weighs in on the announced departures of two senior CBER vaccine officials, pledging suppor...

Asensus Surgical Laparoscopy Device Enhancements Cleared

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FDA clears an Asensus Surgical 510(k) to expand the machine vision capabilities of its previously cleared Intelligent Surgical Uni...

Merck Gains Keytruda Full Approval in Bladder Cancer

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FDA converts Mercks accelerated approval to full approval for its anti-PD-1 Keytruda (pembrolizumab) and its use in first-line tre...

DoJ Changes 2 Guidance Policies: Attorneys

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Attorneys Anne Walsh and JP Ellison describe changes to two Justice Department policies on using guidance documents in enforcement...

CGMP Violations at Turkeys Gulsah Uretim Kozmetik

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FDA warns Turkeys Gulsah Uretim Kozmetik Sanayi Anonim Sirketi about CGMP violations in its production of finished drugs.

FDA Revokes 15 EUAs Granted During Covid

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Federal Register notice: FDA revokes 15 Emergency Use Authorizations on 12 decontamination systems for personal protective equipme...

Two Top CBER Vaccine Officials Leaving FDA

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Two senior CBER vaccine officials announce they are leaving FDA over the next couple of months untimely departures that signal tr...