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CDER issues a MAPP on good review practice for the clinical review of INDs.[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information to the Office of Management and Budget on focus groups a...[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on the device adverse event program.[ Price : $8.95]
Federal Register Notice: FDA seeks comments on a proposed collection of information on a study designed to use eye tracking techno...[ Price : $8.95]
Federal Register Notice: FDA submits a proposed collection of information on designated new animal drugs for minor use and minor s...[ Price : $8.95]
FDA accepts for review an AcelRx Pharmaceuticals NDA for Zalviso (sublingual sufentanil microtablets), a patient-controlled treatm...[ Price : $8.95]
FDA extends by three months its review of a Biogen Idec BLA for Alprolix, an investigational long-lasting recombinant factor IX Fc...[ Price : $8.95]
Abbott recalls 20 lots of FreeStyle and FreeStyle Lite Blood Glucose Test Strips because they may produce erroneously low blood gl...