CGMP/Finished Pharmaceuticals/Adulterated
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FDA Approves Expanded Use of Vonvendi for von Willebrand Disease, Including for Certain Uses for Children
The U.S. Food and Drug Administration today approved expanded use of Vonvendi [von Willebrand factor (Recombinant)] for routine preventative (prophylactic) use in adults (age 18 years and older) with all types of von Willebrand disease (VWD) and on-demand and treatment of bleeding episodes and perioEarly Alert: Anesthesia System Issue from GE HealthCare
GE HealthCare issues updated use instructions for certain Carestation 600 and 700 series Anesthesia SystemsGeneric Drug User Fee Amendments
FDA is soliciting general comments on GDUFA II Program Fee: List of Abbreviated New Drug Application Sponsors and Application Numbers. The information gathered from public comments will assist FDA in accurately assessing FY 2018 GDUFA Program Fees in a timely manner.CSL Behring – 716297 – 09/09/2025
Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps)www.portmeds.com – 711585 – 07/16/2025
Unapproved New Drugs/MisbrandedAzurity Pharmaceuticals, Inc. – 656489 – 09/20/2024
CGMP/Finished Pharmaceuticals/Adulterated/Unapproved New Drug