Blog Archive

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

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FDA ROUNDUP: FDA issues important draft guidance for developers of psychedelic drugs for potential treatment of medical conditions (June 23, 2023).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...