Day: December 4, 2025

The FDA has issued an updated version of its eCopy Program guidance, providing clarifications to an established electronic submission framework in place for more than a decade. The revisions primarily refine expectations, align terminology, and integrate the program more closely with eSTAR and current electronic submission pathways. For medical device sponsors, the document functions as … Read more

Animal testing has long been considered a necessary step in drug development; however, the FDA is now revising that narrative. A new draft guidance aims to modernize outdated toxicology practices and significantly reduce the use of animals in the development of monoclonal antibodies. This shift not only reflects scientific progress but also a broader commitment … Read more