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FDA says the Abiomed recall of certain Impella CP Sets with SmartAssist is Class 1.[ Price : $8.95]
FDA says an Insulet recall of specific lots of its Omnipod Pods is Class 1.[ Price : $8.95]
FDA selects seven companies from 80 applications to participate in the agencys PreCheck Pilot Program to advance U.S. drug manufac...[ Price : $8.95]
FDA publishes a guidance on submitting next-generation sequencing data to CDERs Division of Antivirals.[ Price : $8.95]
FDA approves Orca Biosystems Tregzi to improve chronic graft-versus-host disease (GVHD)-free survival in adults with blood cancers...[ Price : $8.95]
FDA warns Indias Wizcure Pharmaa about CGMP violations in its production of over-the-counter drugs.[ Price : $8.95]
FDA warns Chinas Yangzhou Hongshengding Chemical Co. about not responding to agency requests for records on its over-the-counter d...[ Price : $8.95]
CBER publishes a Standard Operating Policy and Procedure on implementing and maintaining REMS.