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Penumbra Recalls Reperfusion Catheter 032

[ Price : $8.95]

Penumbra recalls 77 reperfusion catheter 032s due to a manufacturing error that endangers patients experiencing stroke.

FDA OKs Agri Labs sANADA for Dairy Cows

[ Price : $8.95]

Federal Register Final rule: FDA approves an Agri Laboratories sANADA for use of flunixin meglumine solution for control of pyrexi...

FDA OKs Huvepharma ANADA for Bacterial Diseases

[ Price : $8.95]

Federal Register Final rule: FDA approves a Huvepharma ANADA for using tylosin tartrate in drinking water to control various bacte...

FDA Approves 2nd Collagenase Manufacturing Facility

[ Price : $8.95]

FDA approves a second production facility for making Healthpoint's Collagenase Santyl Ointment, a biologic enzymatic debriding age...

FDA Seeks Participants in Biosimilar User Fee Program

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Federal Register Notice: FDA asks that public stakeholders notify the agency if they intend to participate in consultation meeting...

FDA Grants Opana Bioequivalence Limit

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FDA grants one part and denies other parts of an Endo Citizen Petition on bioequivalence of generic forms of Opana ER.

QS Problems Found at Steris Isomedix Facility

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FDAs Dallas District Office warns Steris Isomedix about Quality System violations in its contract sterilization of medical devices...

Intellipharmaceutics ANDA for Generic Focalin

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Intellipharmaceutics International submits an ANDA for a generic copy of ADHD drug Focalin XR (dexmethylphenidate hydrochloride) 3...

No Support Found for Whistleblower GAO Complaints

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The Government Accountability Office inspector general says no evidence was found to substantiate whistleblower allegations that G...

FDA Temporary Budget Extended for Two Weeks

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President Obama approves a temporary FDA budget extension until 12/18 for FY 2011 under a continuing resolution.