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Latest FDA-483s, EIRs Received from FDA

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We post inspection documents for BioMed International, Chemrich, Cincinnati Sub-Zero, Eqyss, June Jacobs, Pascal Co., Peoples Phar...

Stents Associated with Increased Thrombosis Risk

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A Cleveland Clinic analysis shows a small but real increased risk of late stent thrombosis when drug-eluting stents are used.

Teva Educating on Inhaler Switch

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Teva says it is working with the American Lung Association on educating asthma patients about conversion from CFC-containing albut...

FDA Panel Backs Celebrex in Juvenile RA

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FDAs Arthritis Drugs Advisory Committee 11/29 votes to recommend approval of Pfizers Celebrex (celecoxib) for use in juvenile rheu...

Blood Products Panel to Discuss Oxygen Carrier

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Federal Register Notice: FDAs Blood Products Advisory Committee will meet 12/14.

ACOG Nixes Paxil in Pregnancy

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The American College of Obstetricians and Gynecologists cautions against use of Paxil and other antidepressants by pregnant women ...

FDA Clears Possis Xpeedior Catheter

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FDA clears a Possis Medical 510(k) for its AngioJet Xpeedior catheter, intended to be used to remove blood clots from upper- and l...

White House Rebuffs Plan B Subpoena

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The White House balks at a subpoena for production of its documents in a New York case against FDA alleging political interference...

FDA Chief of Staff Patrick Ronan Resigns

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After 2 years at FDA, chief of staff Patrick Ronan resigns to recharge my batteries and spend time with his family before deciding...

Famulare, Friedman Promoted at CDER

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CDER Division of Manufacturing and Product Quality (DMPQ) director Joe Famulare moves up the ladder to Office of Compliance deputy...