Blogs

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

Come explore with us at the 2023 SNMMI Therapeutics Conference. September 21-23 Find us in Booth #16 Regulatory guidance and support designed specifically for radiopharm More radiopharm open INDs and approved NDAs than anyone i...

FACET BY THE NUMBERS Total submissions to FDA April – June 2023:  35 (on average almost 3 submissions a week!) Early-stage development highlights: preparation/submission of 3 new INDs and submitted over 22 IND amendments (e.g.,...

FDA ROUNDUP: FDA issues important draft guidance for developers of psychedelic drugs for potential treatment of medical conditions (June 23, 2023).  Currently, there are hundreds of organizations across the world who are develo...

DID YOU KNOW? Facet helps to develop products in every therapeutic area and has specialty expertise in ophthalmology, oncology, diagnostic/therapeutic radiopharmaceuticals, and controlled substances Facet’s scientific experts ...

Team FocusDr. Jason Mercer attended the annual Food and Drug Law Institute (FDLI) annual conference May 17-18 in Washington, DC.  The FDLI annual conference addresses complex legal, regulatory, compliance, and policy issues fac...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS ULTRA RARE DISEASE DEVELOPMENT: Facet helps growing start-up design a development plan for a pediatric ultra rare disease indication. A small ex-US company asked Facet to pro...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTSULTRA RARE DISEASE DEVELOPMENT: Facet helps growing start-up design a development plan for a pediatric ultra rare disease indication. A small ex-US company asked Facet to provide US...

FACET BY THE NUMBERS Total submissions to FDA January – March 2023:  41 (on average over 3 submissions a week!)  Early-stage development highlights:  preparation/submission of 7 new INDs and submitted over 20 IND amendments (e....