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WLF Urges Reinstatement of Viropharma Suit

[ Price : $8.95]

The Washington Legal Foundation urges an appeals court to reinstate a dismissed lawsuit challenging an FDA rule that makes it easi...

Somaxon Seeks Restrictions on Generic Silenor ANDAs

[ Price : $8.95]

Somaxon asks FDA not to approve ANDAs for generic Silenor than dont meet bioequivalence requirements sought by the company.

Info on Veterinary Feed Directive Sent to OMB

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Federal Register Notice: FDA submits a proposed collection of information on the veterinary feed directive to the Office of Manage...

Workshop on Pediatric Device Claims

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Federal Register Notice: FDA plans a public workshop 12/5 on using scientific research data to support pediatric medical device cl...

Medtronic Assurant Cobalt Iliac Stent Approved

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FDA approves a Medtronic PMA for the Assurant Cobalt Iliac Balloon-Expandable Stent System.

FDA OKs Gen-Probe Human Papillomavirus Assay

[ Price : $8.95]

FDA approves a Gen-Probe PMA for its Aptima HPV assay, an amplified nucleic acid test that detects high-risk strains of human papi...

CDRH Report Examines Barriers to Device Quality

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A new CDRH report says greater visibility on the agency's expectations of device quality and properly aligning its regulatory appr...

Vytorin Reduces CV Events in Kidney Disease Patients: FDA

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FDA says clinical data suggest that Merck/Schering Ploughs Vytorin (ezetimibe and simvastatin) is effective in reducing the risk o...

Obama Signs Order to Curb Drug Shortages

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President Obama signs an Executive Order directing FDA to take further steps to help further prevent and reduce prescription drug ...

FDA OKS Roche PMA for Hepatitis B Assay

[ Price : $8.95]

FDA grants Roche PMA approval for its Anti-HBc IgM assay for the in-vitro qualitative determination of IgM antibodies to hepatitis...