CDER researchers say that more research is needed to determine the most appropriate approaches for statistical and analytical methodologies for patien...
FDAs Medical Device Single Audit Program issues a guideline on a five-level nonconformity grading system for medical devices.
The 13th Annual Sentinel Initiative Virtual Public Workshop 11/8-9 features a keynote address from CDER director Patrizia Cavazzoni.
FDA makes three revisions to a guidance containing questions and answers on developing ANDAs during the Covid-19 pandemic.
FDA and the Duke-Margolis Center for Health Policy schedule a public meeting on the agencys plan to reconsider the need for mandatory opioid prescribe...
FDA clears a joimax 510(k) for the EndoLIF Delta Cage and EndoLIF DoubleWedge Cage, intended for intervertebral body fusion procedures.
FDA warns Genesis Ultra Slim that its Ultra Slim Gold is a misbranded unapproved new weight loss drug.
FDA approves Impel NeuroPharmas Trudhesa migraine nasal spray treatment.