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Latest FDA Warning Letters

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In its latest batch of Warning Letters, FDA cites Qiagen and Randall K. Wolf.

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...

Neurochem Responds to FDA on Kiacta

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Neurochem responds to an FDA approvable letter for its Kiacta, for the proposed indication of Amyloid amyloidosis.

Crawford to Plead Guilty Over Unreported Stocks

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Former commissioner Lester Crawford is charged with two criminal misdemeanors related to stock holdings and conflicts of interest,...

Warwick Moving Away from CFC Inhalers

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FDA says Schering-Ploughs Warwick Pharmaceutical will begin 11/1 to shift from CFC-based albuterol inhalers to HFA-based inhalers ...

Industry Sneaks Regulatory Issues in Critical Path Meetings

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CDER Office of Translational Sciences director Shirley Murphy says some companies have been blindsiding reviewers with unrelated r...

Counterfeit One Touch Test Strips Reported

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FDA issues a nationwide alert for counterfeit blood glucose test strips to be used in LifeScan One Touch monitors.