Generic drug user fees make it possible for FDA and industry to continue to ensure that the American public has access to safe, effective and high-quality generic drugs. The implementation of the Generic Drug User Fee Amendments (GDUFA) encompasses a wide range of activities that fall within the sco
Similar Posts
Correction Alert: Olympus Updates Use Instructions for Ligating Device
Olympus ligation loops may be unable to release or detach as expected during use and may become unintentionally anchored around patient anatomy
Early Alert: Anesthesia System Issue from GE HealthCare
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia SystemsConvenience Kit Recall: Medline Industries, LP, Removes Medline Neonatal and Pediatric Kits containing Smiths Medical ORAL/NASAL Endotracheal Tubes Due to Smaller Than Expected Tube Diameter That May Cause Underventilation
Medline Neonatal and Pediatric convenience kits that include Smiths Medical ORAL/NASAL Endotracheal Tubes are used for intubation.About CDER Small Business and Industry Assistance (SBIA)
CDER Small Business and Industry Assistance (SBIA) helps small pharmaceutical business and industry navigate the wealth of information that FDA offers, and provides assistance in understanding the regulation of human drug products.Catalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025
Catalent Indiana LLC, Bloomington, IN 483 Issued 07/14/2025B. Braun Medical Issues Voluntary Nationwide Recall of Lactated Ringer’s Injection USP 1000 mL and 0.9% Sodium Chloride Injection USP 1000 mL Due to the Presence of Particulate Matter
For Immediate Release – BETHLEHEM, PA – August 19, 2025 – B. Braun Medical Inc. (B. Braun) is voluntarily recalling two lots of Lactated Ringers Injection USP 1000 mL,and 0.9% Sodium Chloride Injection USP 1000 mL to the hospital level due to the presence of particulate matter inside the container.