Blog Archive

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....

FDA ROUNDUP: Rare Disease Day:  On February 27, 2023, FDA hosted a virtual Rare Disease Day the purpose of which was to explore patient and patient advocate engagement in supporting the development of products for rare diseases...

DID YOU KNOW? Facet only works with smaller life sciences companies, academic institutions, or nonprofit organizations to help get their products to and through FDA Facet was regulatory lead for two US marketing approvals in 2...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTS INDUSTRY FIRST FOR MEDICAL DEVICES:   Facet is the first organization to work with the FDA and a medical device Sponsor to prepare and submit a combination product 510(k) usi...

RECENT FACET SUCCESSES – JUST A FEW HIGHLIGHTSINDUSTRY FIRST FOR MEDICAL DEVICES:   Facet is the first organization to work with the FDA and a medical device Sponsor to prepare and submit a combination product 510(k) using the ...

Facet is on the cutting edge again! Congratulations to Dr. Bill Hodnick on his upcoming publication. “Potential Use of the Mitomycin Analogue BMY25282 as a Superior Hypoxia Targeted Anticancer Agent”