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FDA clears a NeuMoDx Molecular 510(k) for its NeuMoDx 288 Molecular System and its NeuMoDx GBS [Group B Streptococcus] Assay.[ Price : $8.95]
FDA issues a draft guidance on Information Requests and Discipline Review Letters Under GDUFA that outlines how such letters will ...[ Price : $8.95]
FDA improves transparency in a revised listing that identifies brand drugs that do not have any generic competition.[ Price : $8.95]
FDA releases a draft guidance on Investigational IVD Used in Clinical Investigations of Therapeutic Products to help researchers i...[ Price : $8.95]
FDA lifts a clinical hold on Alnylam Pharmaceuticals clinical studies with fitusiran, indicated for treating patients with hemophi...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled The Least Burdensome Provisions: Concept and Principles tha...[ Price : $8.95]
Federal Register notice: FDA issues a priority review voucher to Ultragenyx Pharmaceutical for obtaining approval of a rare pediat...[ Price : $8.95]
Federal Register correction notice: FDA corrects an 11/27 notice entitled Safety Assessment for Investigational New Drug Safety Re...