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Device Inspections Scrutinize Corrections and Removals

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CDRH special assistant Casper Uldriks says FDA investigators are closely examining medical device Corrections and Removals reporti...

Fixed Dose Combo HIV Drug Guidance Out

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FDA issues a guidance for sponsors submitting applications for HIV fixed dose combination therapies.

New Type of Diabetes Treatment Approved

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FDA approves Mercks Januvia for treating Type 2 diabetes alone or with two other common diabetes drugs.

Qiagen Reagents Have Not Been Approved

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FDA says Qiagen GmbH does not have an approved PMA for ASRs it is marketing directly to clinical laboratories.

Crawfords Fall Emblematic of a Wider Decay

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FDA Webview editor James G. Dickinson says the Crawford plea bargain makes the former commissioner emblematic of a wider decay in ...

FDA Debars Butkovitz

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Federal Register Notice: FDA issues an order permanently debarring Anne L. Butkovitz from providing services to a person with a pe...

FDA Needs More Authority on Compounding: Grassley

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Sen. Grassley says FDA needs more legal authority to deal with compounded inhalation drugs.

FDA Wants Plan B Case Dismissed

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FDA tells a federal judge it wants the Center for Reproductive Rights suit over Plan B dismissed since the drug is now available O...

TyRx Submits 510(k) for Mesh Pouch

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TyRx Pharma submits a 510(k) to FDA for its Pivit CRM antimicrobial mesh pouch for pacemakers and pulse generators.

FDA Clears Pegasus Wound Dressing

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FDA clears a Pegasus Biologics 510(k) application to market its DermADAPT Biomatrix Wound Dressing for locally managing moderate t...