Based on new information, the Endologix AFX with Strata device is at greater risk for a Type III endoleak compared to other endovascular AAA graft systems.
FDA - U.S. Food and Drug Administration
The guideline is an annex to the VICH parent stability guideline, stability testing of new veterinary drug substances and medicinal products (VICH GL3 (R)), and provides guidance regarding the stability data package for a new veterinary drug substance and medicinal product to be included in a registration application submitted within the regions in the climatic zones III and IV.
Europe - EMA - European Medicines Agency
Human coagulation factor VIII (Active substance: Human coagulation factor VIII) - Corrigendum - Commission Decision (2017)7630 of Thu, 08 Mar 2018
Europe -DG Health and Food Safety