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FDA accepts for filing the resubmission of a Fennec Pharmaceuticals NDA for Pedmark.[ Price : $8.95]
FDA clears a CoreLink 510(k) for the F3D Corpectomy VBR System, a vertebral body replacement that is intended to surgically replac...[ Price : $8.95]
FDA extends the comment deadline for a discussion paper on how medical device materials information could be communicated.[ Price : $8.95]
Attorney Josephine Torrente says drug sponsors disagreeing with FDA over a Phase 3 protocol have no right of appeal and could cons...[ Price : $8.95]
FDA warns Molecular BioLife it is marketing misbranded unapproved new drugs via a Web site.[ Price : $8.95]
Former FDA chief counsel Stacy Cline Amin joins Morrison & Foerster as a partner in its life sciences/healthcare practice.[ Price : $8.95]
Agios Pharmaceuticals files an NDA for mitapivat for treating adults with pyruvate kinase deficiency.[ Price : $8.95]
Researchers say FDA guidance on external controls in drug trials should be revised to reflect the use of retrospective natural his...