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PhRMA says FDA should refine its approach to REMS requirements.[ Price : $8.95]
Mayo Clinics PET facility asks FDA to change the highest strength of a reference-listed drug used in imaging studies.[ Price : $8.95]
FDA sends Genentech a refuse-to-file letter on its BLA for trastuzumab-DM1 (T-DM1), seeking accelerated approval for treating brea...[ Price : $8.95]
FDA approves a Novartis NDA for Tekamlo (aliskiren and amlodipine) tablets, a combination pill for treating high blood pressure.[ Price : $8.95]
Federal Register Final rule: FDA amends the animal drug regulations to reflect change of sponsor for a NADA from Peptech Animal He...[ Price : $8.95]
Federal Register Notice: FDA withdraws approval of 2 Pegasus Labs NADAs for Tiny Tiger Worming Capsules and LK Worming Capsules.[ Price : $8.95]
FDA clears a SonoSite 510(k)for the LumenVu Catheter Guidance System.[ Price : $8.95]
FDA announces a Class 1 recall of certain lots of Multi-Med, Inc. Huber needles that were found to core or remove silicone slivers...