Blog Archive

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS FACET HELPS SMALL ORGANIZATION HOLD SUCCESSFUL FDA MEETING Small organization reaches FDA agreement on BLA requirements for novel diagnostic in Type C meeting.  Facet often w...

From The Corner Office Q1 2024Ken VanLuvanee, President & CEO   It’s been a busy and fun quarter at Facet.  Not only have we rapidly expanded our team roster, but we’ve also added new service lines and restructured Facet’s ...

Facet Life Sciences, a leading provider of regulatory strategy and consulting services, has been recognized for the second year in a row as one of the top ten regulatory companies for 2024 by Life Sciences Review. We ...

In February, Facet will be launching a Strategic Commercialization Services group that helps organizations understand and build health economics, market access, product launch, and reimbursement planning into their product deve...

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...

FACET BY THE NUMBERS Early-stage development highlights:  3 IND preparation and submissions for NCEs, 3 IND clearances; over 35 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study reports, annual repo...

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...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS  FACET HELPS PHYSICIAN GET IND FULL HOLD LIFTED Facet successfully prepares Complete Response (CR) to Investigator IND full hold to allow PI to proceed into the clinic.  FDA ...