Industry & Company News

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...

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 ...

Ken 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 clients, and advanced s...

Congratulations to Dr. Jason Mercer ! Dr. Jason Mercer has been chosen to serve as a committee member on the Food and Drug Law Institute’s (FDLI) Medical Products committee this year.  As part of the committee, Dr. Mercer...

Partner News Facet is delighted to announce a partnership with Veramed.  Veramed is a pioneering CRO redefining intelligent healthcare decision-making.  As trusted industry specialists, Veramed’s global team provides next-level...

FDA ROUNDUP: FDA Issues New User Fees for 2023-2024 – Costs Are Going Up! If you are submitting an NDA or BLA application that includes clinical data in 2023 or 2024, you will pay $3.24M, and a whopping $4.04M, respectively!  P...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTSFACET HELPS GOVERNMENT INVESTIGATE DEA DRUG OF CONCERN: Facet champions IND preparation and submission to study PK and safety of widely available supplement.  A large ex-US CRO and ...