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Federal Register Notice: FDA submits a proposed collection of information on a draft guidance on safety labeling changes to the Of...[ Price : $8.95]
Federal Register Notice; FDA plans a public hearing 12/18 to gain input on establishing a list of qualifying pathogens that have t...[ Price : $8.95]
FDA cites Janssen Biotechs Malvern, PA facility for failing to adequately investigate unexplained discrepancies related to Remicad...[ Price : $8.95]
Cumberland Pharmaceuticals files a lawsuit against FDA challenging the agencys decision to deny a citizen petition and approve Inn...[ Price : $8.95]
FDA clears a Quantel Medical 510(k) for its SupraScan 577 Laser, an ophthalmic laser system for treating a wide range of retinal d...[ Price : $8.95]
Federal Register Notice: FDAs Neurological Devices Panel will meet 12/10 to discuss the safety and effecitiveness of the CoAxia Ne...[ Price : $8.95]
Federal Register Notice: FDA releases a compliance guidance for small businesses on labeling for OTC bronchodilators.[ Price : $8.95]
AcelRx Pharmaceuticals reports that a Phase 3 study of its ARX-01 sublingual Sufentanil NanoTab PCA (patient-controlled analgesia)...