[ Price : $8.95]
Fresenius Medical asks FDA and other agencies to ensure that there is no regulatory overlap or unintended consequences in regulati...[ Price : $8.95]
FDA clears a Royal Philips Electronics 510(k) for the EPIQ ultrasound system.[ 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Federal Register Notice: FDA releases a draft guidance: Select Updates for Non-Clinical Engineering Tests and Recommended Labeling...[ Price : $8.95]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]
Attorneys Brian Dunphy and Ellyn Sternfield say federal judges are beginning to question whether to permit False Claims Act suits ...