Zdrowie i gospodarka · 13/04/2001

FDA Releases Final Guidance on Stability Testing for Veterinary Biotech Products

The Food and Drug Administration (FDA) has released a final guidance document (VICH GL17) for the stability testing of new biotechnological/biological veterinary medicinal products, adapted from a similar document for human pharmaceuticals. This guidance aims to provide industry with clear requirements for stability studies and data submission in support of new animal drug applications (NADA's) for veterinary products regulated by the FDA and submitted to the EU, Japan, and the US.