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FDA warns Costa Ricas Deroyal Cientifica de Latinoamerica about MDR and QS violations in its manufacturing of medical devices.[ Price : $8.95]
FDA orders labeling changes and revised REMS for extended-release and long-acting opioids.[ Price : $8.95]
FDA issues guidance on when an IND is needed in human research studies.[ Price : $8.95]
FDA Pulmonary/Allergy Drug Advisory Committee members tell the agency there is sufficient safety and efficacy data to support appr...[ Price : $8.95]
FDA warns Graftys about MDR and QS violations in its manufacturing of bone void fillers.[ Price : $8.95]
FDA says a Genentech supplemental BLA contains statistically significant clinical trial results for an expanded use for Perjeta (p...[ Price : $8.95]
FDA releases a draft guidance that outlines a path for generic companies to market copies of GlaxoSmithKlines Advair (fluticasone ...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Generic Drug User Fee Amendments of 2012: Questions and Answers (Revision ...