FDA files NDAs submitted less than six seeks after completion of clinical program – shattering industry standards
WAYNE, PA., DECEMBER 16, 2020 –
Facet Life Sciences, a leading provider of development software and services for small and growing life sciences teams, today announced the achievement of a landmark milestone that redefines accepted industry timelines.
Facet has created a repeatable model that results in the creation of a full NDA, 505(b)1 or (b)2, in less than six weeks that is capable of being filed by FDA. Facet’s NDA creation process has now been successfully applied multiple times with all NDAs successfully filed by FDA. In an industry where this process normally takes 6 to 12 months, these new timelines could reduce the cost of drug development by millions of dollars and increase delivery speed of needed new therapies to patients.
Ken VanLuvanee, President and CEO of Facet Life Sciences, commented, “When we founded Facet, we set out to change how regulatory affairs impacted therapies getting to FDA. This new milestone shows that Facet’s strong, focused RA team powered by our Gemstone EDMS and submission system can deliver not just game changing, but industry changing results.”
About Facet Life Sciences
Facet Life Sciences is the leading provider of innovative development solutions (software and services) designed to help small teams get to and through the FDA©. Our Product Development Champions deliver expert nonclinical, CMC, and clinical regulatory services using cutting-edge technologies that speed product R&D efforts. Facet teams create and manage critical development documentation for some of the industry’s fastest growing, most innovative life sciences companies.