In this overview of the impact of the PDUFA V FDA/industry agreement, Catalyst President Nancy Bradish Myers provides perspective on industry’s position in seeking a new review model for new molecular entities (NMEs). “What the industry wants to avoid is this syndrome: you submit your application and you suffer this radio silence,” Ms. Myers told GEN. “One of the things the regulatory people in the companies are really clamoring for is predictability. I think this series of meetings will really help the people who are running the actual submission understand where the agency is in reviewing their submission. It is very important.”

The article further notes Myers’ comment that what regulatory executives want is the opportunity to “address FDA concerns as soon as they arise, rather than be lulled into thinking all is well, only to be jolted by a complete response letter (CRL) detailing issues that had not come up before.”

“Who wants to be the head of regulatory affairs who gets that surprise complete response letter, and you have to go back and explain to your executive team and your investors why all of a sudden, something you thought was on track isn’t on track?”

FDA Aims to Bridge Communication Gap with Drug Industry During Reviews Through PDUFA V

Genetic Engineering & Biotechnology News