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FDAs New England District Office warns Fresenius over Quality System problems at its Waltham, MA, manufacturing facility for kidne...[ Price : $8.95]
Gen-Probe submits a 510(k) for the Aptima Trichomonas Vaginalis assay and its use on the company's Tigris system.[ Price : $8.95]
Two industry associations voice caution over some of FDAs recommendations for changing the 510(k) process while a citizen advocacy...[ Price : $8.95]
In its latest batch of Warning Letters, FDA cites Absolute Packaging, Actelion Pharma, Amigo Mobility, BCIW, Capricorn Pharma, Fre...[ Price : $8.95]
FDA awards $2.9 million to support six research projects on tuberculosis diagnosis, treatment, and prevention.[ Price : $8.95]
FDA principal deputy commissioner Joshua Sharfstein says that without the ability to impose a REMS, FDA probably would have had to...[ Price : $8.95]
Federal Register Notice: FDA releases its modifications to the list of recognized consensus standards for use in premarket device ...[ Price : $8.95]
Orthovita, Inc. receives FDA 510(k) clearance to market its Vitomatrix Bone Graft Substitute as bone grafting material for use in ...