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The Washington Legal Foundation urges an appeals court to reinstate a dismissed lawsuit challenging an FDA rule that makes it easi...[ Price : $8.95]
Somaxon asks FDA not to approve ANDAs for generic Silenor than dont meet bioequivalence requirements sought by the company.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on the veterinary feed directive to the Office of Manage...[ Price : $8.95]
Federal Register Notice: FDA plans a public workshop 12/5 on using scientific research data to support pediatric medical device cl...[ Price : $8.95]
FDA approves a Medtronic PMA for the Assurant Cobalt Iliac Balloon-Expandable Stent System.[ 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...[ Price : $8.95]
A new CDRH report says greater visibility on the agency's expectations of device quality and properly aligning its regulatory appr...[ Price : $8.95]
FDA says clinical data suggest that Merck/Schering Ploughs Vytorin (ezetimibe and simvastatin) is effective in reducing the risk o...