Year: 2024

Facet Donates to SNMMI’s Mars Shot Facet is proud to be a SNMMI Mars Shot Research Fund donor in 2024.  The goal of this fund is to improve and extend the lives of patients with cancer through innovation with radiopharmaceutica...

Facet Attends SNMMI In June, Dr. Lisa Jenkins VanLuvanee attended the Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting.  SNMMI is an educational, scientific, research, and networking organization focus...

Facet Attends Psychedelic Therapeutics & Drug Development Conference In May, Dr. Jason Mercer attended the Psychedelic Therapeutics & Drug Development Conference.  This conference brought together academic and industry ...

Facet Attends the Market Access Society of America Symposium Dr. Randy Goodman attended the May 21st Market Access Society of America Symposium.  This global conference brings together government and industry experts, researche...

Facet Attends the Food and Drug Law Institute (FDLI) Annual Conference In May, Dr. Jason Mercer attended the Food and Drug Law Institute (FDLI) Annual Conference.  FDLI brings together legal and regulatory professionals that w...

Facet Joins PET CMC Coalition In May, Facet joined the Coalition of PET Drug Manufacturers, a not-for-profit organization that seeks to help PET drug manufacturers to gain and maintain US marketing authorizations for PET drugs ...

START Pilot Program Updates In our 4Q2023 newsletter, we reported on FDA’s Support for clinical Trials Advancing Rare disease Therapeutics (START) Pilot Program.  This program is designed to help facilitate more efficient devel...

New RD Hub On July 17, 2024, the FDA announced that they are establishing a Rare Disease Innovation Hub (the Hub).  The Hub will work with all rare diseases, but will “focus on products intended for smaller populations or for ...

Update on Chinese and Indian Biotech In the Spotlight As we reported in our last newsletter (here), ex-US CDMOs and CROs (especially those in China) have been the subject of US political and growing biopharma industry scrutiny....

Industry Focus: FDA Final Guidance for Laboratory Developed Tests FDA Issues Small Entity Compliance Guide When they originated in 1976, laboratory developed tests (LDTs) were manufactured and used locally for unique or regiona...