Annual Reports published by requirement of FDASIA Section 705
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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 perioNews from Emerging Technology Program (ETP)
CDER’s Office of Pharmaceutical Quality created the Emerging Technology Program to promote the adoption of innovative approaches to pharmaceutical product design and manufacturing.Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
Task Description Request Please post to the OII FOIA Electronic Reading Room
Record Date 11/05/2025
Short Title (70 char) Fresenius Kabi Compounding LLC. Canton, MA. 483 issued 11/05/2025
FEI Number 3013438665
Firm Name Fresenius Kabi Compounding LLC
Record Type 483
State MA
Establishment Type OutsoMedical Procedure Kits Correction: Medline Industries, LP Issues Correction for Medline Craniotomy Kits Containing Codman Disposable Perforators Due to Risk for Device Disassembly
Medline Craniotomy Kits are procedure convenience kits. Kits containing the Codman Disposable Perforator are being corrected by Medline Industries.Completed 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 clarifies policies for compounders as national GLP-1 supply begins to stabilize
The U.S. Food and Drug Administration has determined the shortage of tirzepatide injection, a glucagon-like peptide 1 (GLP-1) medication, has been resolved. Tirzepatide injection has been in shortage since 2022 due to increased demand.