Blogs

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...

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...

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...

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...

RDEA Pilot Program to support the development of novel efficacy endpoints for drugs that treat rare diseases is now accepting proposals!   The goals of the RDEA program are to: 1) advance rare disease drug development through c...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS FACET 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 C...

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 ...

Congratulations to Michelle Byrne! Michelle has just been awarded her RAC. We’re so proud of her achievement. Regulatory Affairs Certification (RAC), is the only post-academic professional credential for regulatory professional...

Come explore new paths with us at the 2023 AusBiotech Conference in Brisbane, Australia. November 1-3 Find us in Booth #21