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Regulatory consulting firm Greenleaf Health adds former FDA field investigator Kristen Grumet as senior vice president for regulat...[ Price : $8.95]
Attorney Jennifer Davidson outlines clarifications included in a draft FDA guidance on submission of field alert reports.[ Price : $8.95]
FDA announces availability of a finalized guidance on orphan drug designation for pediatric subpopulations of common diseases.[ Price : $8.95]
FDA releases a draft guidance entitled Peripheral Vascular Atherectomy Devices Premarket Notification [510(k)] Submissions.[ Price : $8.95]
FDA tells ADMA Biologics that it has closed out an April Establishment Inspection Report issued after a compliance inspection at t...[ Price : $8.95]
AngioDynamics agrees to pay $12.5 million to resolve False Claims Act allegations relating to two medical devices.[ Price : $8.95]
FDAs Pulmonary Allergy Drugs Advisory Committee votes 16 to 3 against approving the use of GSKs mepolizumab as an add-on treatment...[ Price : $8.95]
Federal Register notice: FDA submits to OMB an information collection extension for Permanent Discontinuation or Interruption in M...