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Accupack Midwest, Inc. – 680228 – 08/15/2024
CGMP/Finished Pharmaceuticals/AdulteratedCompleted BsUFA III Deliverables
Since the passage of the Biosimilar User Fee Act (BsUFA) in 2012, user fees have played an important role in expediting the process for the review of biosimilar products.FDA Approves Labeling Changes that Include a Boxed Warning for Immune Effector Cell-associated Enterocolitis Following Treatment with Ciltacabtagene Autoleucel (CARVYKTI, Janssen Biotech, Inc.)
The FDA has received reports of immune effector cell-associated enterocolitis (IEC-EC) in patients who received treatment with CARVYKTI.Advancing Clinical Trial Participation for the LGBTQIA+ Community
Representatives of the FDA were fortunate to attend a community discussion on advancing clinical trial diversity for sexual and gender minority communities to help improve the generalizability of trial results across the entire population of patients who may use medical products.Lawrence Wholesale LLC Recalls Kroger Bagged Frozen Shrimp and Kroger Frozen Shrimp Products Because of Possible Health Risk
Lawrence Wholesale LLC of Vernon, CA is recalling a limited quantity of Kroger bagged frozen shrimp and Kroger frozen shrimp products because they may have been prepared, packed, or held under insanitary conditions whereby they may have become contaminated with Cesium-137 (Cs-137).Intravascular PICC Catheter Recall: Bard Removes PowerPICC Intravascular Catheters
This communication is part of the Communications Pilot to Enhance the Medical Device Recall Program