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FDA OKs Synerx Pharma ANADA for Antifreeze Poisoning

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Federal Register Final rule: FDA approves Synerx Pharmas ANADA for veterinary prescription use of fomepizole injectable solution a...

Guidance on Antibacterial Drug Microbiological Data

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Federal Register Notice: FDA releases a draft guidance on microbiological data for systemic antibacterial drug products.

Sebelius Promises Generic Drugs Push

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HHS secretary Kathleen Sebelius pledges to support proposals to speed FDA approval of generics, work to change laws that block gen...

FDA Clears Zargis Medical Signal X6 Heart/Lung Scanner

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FDA clears Zargis Medical Corp.s Signal X6 heart and lung scanner with the ability to evaluate results locally or remotely through...

Sotradecol Web Pages Broaden Indication, Ignore Risk: DDMAC

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CDERs Division of Drug Marketing, Advertising, and Communications warns Bioniche Pharma on multiple violations in two Web pages fo...

Allogenic Pacreatic Islet Cell Product Guidance

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FDA issues a guidance to help those involved in allogenic pancreatic islet cell clinical studies identify IND data and information...

Panel Recommends Approval of Xiaflex

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FDAs Arthritis Advisory Committee voted unanimously to recommend approval of Auxilium Pharmaceuticals Xiaflex for treating Dupuytr...

Guidance on Microbiological Data for Systemic Antibacterials

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FDA issues a draft guidance telling its thinking on the types of microbiological studies, assessments, and clinical trials needed ...

FDA OKs Boehringer Ingelheim sNADA

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Federal Register Final rule: FDA approves a Boehringer Ingelheim Vetmedica sNADA to revise the safety warning for use of diclofena...

Tysabri PML Reports Still Coming In

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FDA says it is still receiving reports of Tysabri patients developing progressive multifocal leukoencephalopathy.