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FDA Clears Spectranetics VisiSheath Dilator Sheath

[ Price : $8.95]

FDA clears a Spectranetics Corp. 510(k) for its VisiSheath Dilator device for dilating tissue surrounding cardiac leads or as an e...

FDA OKs Amneals Generic Anti-acid

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FDA approves an Amneal Pharmaceuticals ANDA for nizatidine oral solution, 15 mg/mL, a therapeutic equivalent of Braintree Labs Axi...

GSK Warns of Lexiva and Heart Attack

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GlaxoSmithKline says it has modified Lexivas labeling to highlight concerns about heart attack in HIV infected adults treated with...

PDUFA Goals Back on Track, Jenkins Says

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Office of New Drugs director John Jenkins says a two-year hiring push at CDER has added enough new staff that the Center is now ba...

Journalism Groups Seek End to FDA Media Controls

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Major journalism groups ask FDAs Transparency Task Force to set a government-wide example and end restrictions on reporters coveri...

FDA Lifts Clinical Hold on CytRx Sclerosis Drug

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FDA accepts a new trial protocol and lifts its clinical hold on CytRxs arimoclomol for treating ALS.

Update Federal Clinical Trial Policy, Regulations: Paper

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A Seton Hall Law School white paper says that regulations and policy governing clinical trial financial arrangements with investig...

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...