Blog Archive

Facet’s new Strategic Statistical Services group uses statistical principles and methodologies to maximize precision and efficiency in the development of drugs, biologics, medical devices, and combination products.  More and mo...

FDA ROUNDUP: New FDA guidance: Stimulant Use Disorders:  Developing Drugs for Treatment (Draft October 2023) – The purpose of this guidance is to provide Sponsors with recommendations on clinical development of drugs for ...

DID YOU KNOW? Facet’s strategic and tactical regulatory affairs, statistics, regulatory writing, and commercialization experts lead small organizations to faster and more efficient product development, US registration, and com...

FDA Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.  Early in 4Q2023, the FDA announced a pilot program for Sponsors of drug or biological products currently in clinical trials under an ac...

From The Corner OfficeKen VanLuvanee, President & CEO   It was a wonderful 2023 for the team at Facet Life Sciences.  We had some fun, welcomed several new team members into the Facet family, joined hands with several new c...

We recently caught up with Jason Mercer, Strategic Program Champion at Facet Life Sciences about what it is like to work at facet and some of his favorite milestones. Favorite Projects One of my favorite projects was a combinat...

Facet Life Sciences Holiday Gift Guide: Because Even Santa Needs Regulatory Expertise! US Agent – The Yuletide Ambassador:    Gift the ‘US Agent’ service for the friend who needs a reliable representative i...

We recently caught up with Bill Hodnick, Product Development Champion at Facet Life Sciences about what it is like to work at facet and some of his favorite milestones. Favorite Projects I’ve worked on a lot of interestin...

FACET BY THE NUMBERS Total submissions to FDA July – Sept 2023:  over 40 (over 3 submissions a week!) Early-stage development highlights: prepared/submitted 2 INDs for new chemical entities and over 30 IND amendments (e.g., new...

DID YOU KNOW? Facet is on a mission to help small organizations bring great science and innovative products to and through FDA. Many small organizations waste significant money and time running large nonclinical programs to su...