Banu Saritas-Yildirim, Senior Director of Regulatory Affairs at Natera Inc. and Former FDA reviewer, shared a post on LinkedIn:
“Another approval for Signatera!
After the FDA approval in May, now Signatera is approved in Japan! This is great news for Japanese colorectal cancer patients and families. Physicians can now better assess who benefits from chemotherapy and monitor patients for recurrence.
I am grateful to Tiffany Hsueh in my team for leading this project to successful approval. Together, we figured out the Japanese regulatory system like no other!
I am thankful to our review team at PMDA for their thorough review of our application. And MHLW for the PMA approval!
Many thanks to GALAXY clinical trial participants for contributions to advance precision oncology.”
Other articles featuring Banu Saritas-Yildirim on OncoDaily.