Day: October 1, 2026

Developing an innovative biologic for two major regulatory markets can sometimes feel like solving the same problem twice. FDA and EMA may ask similar questions, but that does not mean they will always give the same answers. That is where Parallel Scientific Advice (PSA) can make the development conversation much more coordinated. Instead of navigating … Read more

For medical device companies, FDA review time is more than a number on a performance chart, it can determine how quickly an innovation reaches patients. MDUFA V promised to make the regulatory process more efficient, predictable, and transparent. Now, an independent assessment by Booz Allen Hamilton provides a detailed look at what actually changed. The … Read more