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FDAs Medical Device Single Audit Program issues a guideline on a five-level nonconformity grading system for medical devices.[ Price : $8.95]
The 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9 features a keynote address from CDER director Patrizia Cavazzon...[ Price : $8.95]
FDA makes three revisions to a guidance containing questions and answers on developing ANDAs during the Covid-19 pandemic.[ Price : $8.95]
FDA and the Duke-Margolis Center for Health Policy schedule a public meeting on the agencys plan to reconsider the need for mandat...[ Price : $8.95]
FDA clears a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion proced...[ Price : $8.95]
FDA warns Genesis Ultra Slim that its Ultra Slim Gold is a misbranded unapproved new weight loss drug.[ Price : $8.95]
FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.[ Price : $8.95]
FDA approves a TransMedics Group PMA for its OCS Heart System for use with organs from donors after brain death.