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AST Special Controls Guidance Out

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FDA issues a guidance supporting reclassification of the antimicrobial suspeceptibility test system into Class 2 (special controls...

New Medication Guides Issued

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FDA publishes new and updated Medication Guides.

Recalled Childrens Tylenol Due to Bacteria

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FDA says McNeil Consumer Healthcare has recalled certain childrens Tylenol oral suspension products due to the potential of bacter...

Panel to Discuss Pharmaxis Bronchial Test

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 11/20 to discuss Pharmaxis NDA for Aridol to as...

Panel to Discuss Xolair for Asthma

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Federal Register Notice: FDAs Pulmonary-Allergy Drugs Advisory Committee will meet 11/18 to discuss Genentech and Novartis BLA sup...

FDA OKs JHP Pharmas Revised Dantrium IV

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FDA approves a JHP Pharmaceuticals supplemental NDA for Dantrium IV (dantrolene sodium for injection), indicated for treating mali...

Vista Cord Told to Stop Manufacturing HCT/Ps

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CBER orders Vista Cord to stop manufacturing and processing any human cells, tissues, and cellular and tissue-based products due t...

Former FDA Investigator Joins Nixon Peabody

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Former FDA medical device investigator Seth A. Mailhot joins Nixon Peabody as head of its Washington, DC-based FDA regulatory prac...

Bush Era Compromised FDAs Leadership, Reputation

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Washington commentator Robert F. Steeves reviews the latest Bush-era scandal to rock FDA and says theres a taint on all FDA action...

Amalgam Lawyer Appeals Dispute Resolution Denial

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An Oklahoma lawyer appeals this weeks denial by CDRHs ombudsman of a request he made to use the Centers alternative dispute resolu...