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DTC is Least Used Form of Drug Promotion: CBO

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A Congressional Budget Office report says that companies rely much more on detailing and other forms of professional promotion tha...

FDA Actions, Not Legal Costs, Threaten TMJIs Market Viability: CEO

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TMJ Implants CEO Robert Christensen responds to FDA Webview commenters, denying that legal costs rather than civil money penalties...

Norpramin Warning Strengthened

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Sanofi-Aventis cautions healthcare professionals about prescribing Norpramin in patients with a family history of sudden death, ca...

Javelin NDA for Injectable Diclofenac Sodium

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Javelin Pharmaceuticals submits an NDA for Dyloject (diclofenac sodium) Injection, indicated for managing acute moderate-to-severe...

FDA Fast Track for Multiple Myeloma Drug

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FDA grants fast track status to Keryx Biopharmaceuticals for KRX-0401 (perifosine), an oral anti-cancer agent that inhibits the ph...

FDA OKs Dyax NDA With REMS

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FDA approves a Dyax NDA for Kalbitor (ecallantide), indicated for treating hereditary angioedema (HAE) acute attacks.

TMJ Implants Seeks En Banc Review of Appellate Loss

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Embattled device maker TMJ Implants petitions the 10th Circuit Court of Appeals to grant an en banc review of an October decision ...

Objectionable Conditions Seen at Centra IRB

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CDRH warns Centra Health IRB about violations of regulations intended to ensure that accurate data are submitted with medical devi...

Drug Fact Boxes Questioned, Defended

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An Australian physician raises questions about the worth of U.S. research showing that including drug fact boxes in DTC ads helps ...

FDA Clears OIS Portable EyeScan

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FDA clears an Ophthalmic Imaging Systems 510(k) for the OIS EyeScan, a new portable imaging device that provides imaging of the ey...