[ Price : $8.95]
Federal Register Notice: FDA corrects an address in an 8/12 Federal Register notice announcing a workshop on a mobile medical appl...[ Price : $8.95]
CDRH official Alberto Gutierrez tells an industry conference that FDAs approach to regulating laboratory-developed tests can somet...[ Price : $8.95]
Abbott asks FDA to conduct a rulemaking to modify the procedures applying to therapeutic equivalence ratings for 505(b)(2) new dru...[ Price : $8.95]
Hospira says a Phase 1 trial on a proposed biosimilar of erythropoietin (EPO) in patients with renal dysfunction met its key endpo...[ Price : $8.95]
Gilead Sciences says it is discontinuing dosing of an investigational hepatitis C drug in some clinical trials due to adverse even...[ Price : $8.95]
Cytomedix submits a 510(k) for an expanded use for its Angel Whole Blood Separation System processing a bone marrow aspirate.[ Price : $8.95]
Public Citizen endorses a recent Institute of Medicine (IoM) report that is critical of the agency''s 510(k) medical device cleara...[ Price : $8.95]
Fortune magazine reports on Mela Sciences seven-year continuing effort to gain CDRH approval of its non-invasive, 98% effective di...