The International Council for Harmonization publishes a draft version of its E6 good clinical practice guideline.
A European Medicines Agency safety review says Johnson & Johnsons Covid-19 vaccine continues to have a favorable benefit-risk profile but it should ca...
FDA places a clinical hold on a KalVista Pharmaceuticals proposed Phase 2 clinical trial of KVD824 for preventing hereditary angioedema attacks.
FDA says a Medtronic recall of 93 units of its Bio-Console 560 blood pumping console due to potential electrical failure is Class 1.
FDA releases summaries of two PDUFA 7 negotiating sessions by the FDA/industry pre-market subgroup.
FDA releases its latest batch of Warning Letters that includes one medical product company Hou Fu Biotech.
FDA clears a Zimmer Biomet 510(k) for the Rosa Partial Knee System for robotically-assisted partial knee replacement surgeries.
The DC Circuit Court of Appeals affirms a lower court decision that FDA is not afforded discretion when a combination product meets the definition of ...