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FDA releases a draft guidance on Qualification of Biomarker Galactomannan in studies of treatments of Invasive Aspergillosis that...[ Price : $8.95]
FDA clears a Centric Medical 510(k) for its Tarsa-Link system for internal bone fixation of fractures, fusions, and osteotomies in...[ Price : $8.95]
Biogen Idec confirms the first case of progressive multifocal leukoencephalopathy associated with a patient taking the companys ne...[ Price : $8.95]
CDER director Janet Woodcock says a new natural history online tool developed with the National Organization for Rare Diseases can...[ Price : $8.95]
A California Healthcare Institute report sees some improvement in CDRH review times and processes, but says there is still more th...[ Price : $8.95]
FDA notifies Cytori Therapeutics that it can continue enrollment in its ATHENA cardiovascular trials thanks to data and protocol a...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance for tissue establishments and professionals: Same Surgical Procedure Except...[ Price : $8.95]
Teva asks FDA to require a dose counter in any generic form of its QVAR inhalation aerosol.