Blogs

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...

Supreme Court Overrules Chevron Deference; What Now? June 28, in a case known as Loperbright Enterprises v. Raimondo (Loperbright), the United States Supreme Court overturned a 40-year-old precedent known as Chevron deference. ...

FACET BY THE NUMBERS Total ESG submissions to FDA Jan – Mar 2024:  over 30! Early-stage development highlights:  led 2 formal FDA meetings, over 25 IND amendments (e.g., new protocols/amendments, CMC updates, nonclinical study ...

FDA ROUNDUP: FDA Urges Sponsors to Conduct Third Party Validations Prior to Submission – Since the start of 2024, there have been several high-profile cases in which unreliable, incorrect, and even fabricated data have be...

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...

FACET’S REGULATORY INNOVATION HUB HIGHLIGHTS 2 NEW CBER APPROVED PRODUCTS By Dr. Jason Mercer, RAC On March 7, the CBER updated the list of biologic products that have been approved in 2024.  So far, there have been two: Casge...

We’re so proud of our team members’ achievements! DANA BLUE APPOINTED TO AMWA 2024 ANNUAL CONFERENCE COMMITTEE For the second year in a row, Dana Blue, Facet Strategic Program Champion has been asked to serve on the...