Day: April 27, 2023

he Center for Veterinary Medicine (CVM) at the FDA has been accepting applications for new products electronically for a few years. But since CVM applications and documents follow a very different format compared to those for the human drugs and biologics, it has been confusing for companies to understand the acceptable electronic submission process. A … Read more

More than half of the cancer drugs are approved by the FDA based on non-randomized single-arm trials using surrogate endpoints. Also, many drugs for ultra-rare diseases with few or no options are approved based on open-label studies since including a placebo or a standard of care control arm is not feasible or ethical in those … Read more