[ Price : $8.95]
FDA clears a Fujirebio Diagnostics 510(k) for the company's HE4 Test in an algorithm called ROMA and its use in assessing whether...[ Price : $8.95]
FDAs Philadelphia District Office warns Lehigh Valley Technologies about CGMP violations in its manufacturing of finished drug pro...[ Price : $8.95]
FDAs Philadelphia District Office warns Patient Transfer Systems of quality, MDR, and other violations in its manufacturing of Rap...[ Price : $8.95]
Discovery Labs files its response to a 2009 FDA complete response letter on its NDA for Surfaxin (lucinactant) for preventing resp...[ 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]
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...