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CDER pharmacists Catherine Chew and Lindsay Davison say a new USP naming policy for salt drug substances should help reduce medica...[ Price : $8.95]
FDA deputy commissioner Sally Howard says that while the agency has been slow in issuing guidance for biosimilars, it is reviewing...[ Price : $8.95]
CorMedix, Inc. files an application with FDA seeking Qualified Infectious Disease designation for its Neutrolin Catheter Lock solu...[ Price : $8.95]
Federal Register Notice: FDA releases a draft guidance: Pregnancy, Lactation, and Reproductive Potential: Labeling for Human Presc...[ Price : $8.95]
Federal Register Final rule: FDA amends its regulations on the content and format of Pregnancy, Labor and delivery, and Nursing mo...[ Price : $8.95]
FDA clears an ArtVentive Medical Group 510(k) for its Endoluminal Occlusion System that is intended for use in the peripheral vasc...[ Price : $8.95]
FDA approves an Incyte Corp. supplemental NDA for Jakafi (ruxolitinib) for treating patients with polycythemia vera, a chronic typ...[ Price : $8.95]
FDA clears a Fiagon AG 510(k) for its ear, nose and throat Extended Instrument Set.