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FDA alerts clinical laboratory staff and health care providers about a risk of false results with Thermo Fisher Scientific TaqPath...[ Price : $8.95]
FDA accepts for review a Myovant Sciences NDA for its once-daily, oral relugolix combination tablet (relugolix 40 mg, estradiol 1....[ Price : $8.95]
FDA approves a Genentech BLA for Enspryng (satralizumab-mwge) for treating neuromyelitis optica spectrum disorder in adults with a...[ Price : $8.95]
Federal Register notice: FDA proposes to reclassify non-invasive bone growth stimulators from postamendments Class 3 devices into ...[ Price : $8.95]
CBERs Office of Compliance and Biologics Quality sends East West Health Solutions (Lake City, UT) an untitled letter based on a re...[ Price : $8.95]
FDA issues a final guidance entitled Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank.[ Price : $8.95]
Federal Register notice: FDA amends a 7/23 notice about a 9/15 Pediatric Advisory Committee meeting.[ Price : $8.95]
Federal Register notice: FDA makes available two final device-specific guidance documents for its Safety and Performance Based Pat...