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FDA Orders New Studies on Concordias Kayexalate

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FDA orders Concordia Pharmaceuticals to conduct postmarketing studies to investigate Kayexalates (sodium polystyrene sulfonate) po...

Two Groups Back Pacira Free Speech Bid

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Two drug industry trade groups tell a New York federal court they support Paciras efforts to make truthful and non-misleading stat...

FDA Awards Contract to Study Milled Opioid Bioavailability

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FDA awards a contract to Vince & Associates Clinical Research to conduct a clinical pharmacology pharmacokinetic study of opioids ...

Biogen Tysabri Misses Endpoints in MS Study

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Biogen says its Phase 3 ASCEND study investigating Tysabri (natalizumab) in treating secondary progressive multiple sclerosis did ...

Package Type Guidance Out

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FDA issues a draft guidance revising definitions for packaging types and adding a new definition.

Stop Apotex Neulasta Biosim, Amgen Asks Court

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Amgen asks a Florida federal court to approve an injunction barring Apotex from marketing its Neulasta biosimilar until it gives a...

AZs Lesinurad Side Effects Raised for Committee

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FDA medical reviewers tell the Arthritis Advisory Committee that they have questions about the safety of AstraZenecas new gout dru...

Comments Sought on Device User Fee Form

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Federal Register Notice: FDA seeks comments on the medical device user fee cover sheet, which must be submitted along with certain...

Info on Reducing Tobacco Use Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the agencys campaign to reduce tobacco use among gay,...

OMB OKs Info on Formal Evidentiary Hearing

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Federal Register Notice: The Office of Management and Budget approves a collection of information on administrative practices and ...