Blogs

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”

10 years!! Congratulations to Dr. Lisa Jenkins VanLuvanee. Thank you for your dedication to cutting edge science and for 10 years of extraordinary leadership and guidance.

We’re very proud to recognize Dana B.‘s recent achievements! Dana has accepted a role as a Group Leader on the AMWA Annual Conference Executive Committee. In this role, she is responsible for spearheading a team of indust...

Facet Life Sciences, a leading provider of regulatory strategy and consulting services, has been recognized as one of the top ten regulatory companies for 2023 by Life Sciences Review. We work with clients to understan...

Expertise from our PartnerPotential Errors and Corrections in Early Phase Drug DevelopmentAbstract: Many foreign and small companies trying to enter the United States biopharmaceutical market make avoidable errors in their earl...

Theragnostics Announces US FDA Approval for its Radiodiagnostic Imaging Drug NephroScan™ (Kit for the Preparation of Technetium Tc 99m Succimer Injection) NephroScan is now US FDA approved for the preparation of Tc-99m DMSA Nep...