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The Outsourcing Facilities Association and FDA reach a settlement agreement that compels the agency to promptly review long-pendin...[ Price : $8.95]
Hyman, Phelps & McNamara attorneys and a medical device regulatory expert say an FDA final guidance on clinical decision support s...[ Price : $8.95]
Reuters reports that FDA has again found quality issues at the Lilly Branchburg, NJ, drug manufacturing facility.[ Price : $8.95]
FDA accepts for priority review a Gilead Sciences supplemental BLA for Trodelv (sacituzumab govitecan-hziy) for treating certain a...[ Price : $8.95]
FDA warns Mexicos Eksa Mills about CGMP violations in its manufacturing of finished drugs.[ Price : $8.95]
Federal Register: FDA revokes an emergency use authorization issued to Laboratorio Clinico Toledo, Puerto Rico, for its Laboratori...[ Price : $8.95]
Regeneron Pharmaceuticals and Sanofi say they will seek FDA approval next year for Dupixent (dupilumab) and its use in treating ch...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Facility Readiness: Goal Date Decisions Under GDUFA.