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A Johns Hopkins study says that the number of adverse events associated with robotic surgery may be under-reported.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on submitting information in electronic format to CVM us...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling...[ Price : $8.95]
FDA sends Otsuka a complete response letter on its NDA for tolvaptan for an expanded indication in treating adult patients with ra...[ Price : $8.95]
FDA categorizes Cepheids Xpert MTB/RIF test as moderate complexity under the Clinical Laboratory Improvement Amendments (CLIA).[ Price : $8.95]
PhRMA says FDA has made qualifying criteria for drug and biologic makers to obtain a priority review designation more restrictive.[ Price : $8.95]
FDA clears a Royal Philips Electronics 510(k) for the EPIQ ultrasound system.[ Price : $8.95]
An Epstein Becker & Green white paper says FDA should update its regulatory system to accommodate the new reality of e-health.