Facet Life Sciences, a leader in US regulatory strategy and product development solutions for the life sciences industry, has been named as the US regulatory partner for Cybin Inc. (“Cybin”), a late-stage breakthrough neuropsy...
A life sciences product landscape assessment – also known as a pharmaceutical landscape assessment for drug and biological products and a device landscape assessment for medical device products – arms Sponsors as we...
FDA issued a draft guidance for industry and FDA staff on Chemical Analysis for Biocompatibility Assessment of Medical Devices. Any medical device in which all or part of the device is in contact with the human body requires an...
FDA issued Revision 2 of the guidance for industry Control of Nitrosamine Impurities in Human Drugs. As a class of compounds, nitrosamines are potent genotoxins both in vitro and in several animal species. Some nitrosamines a...
In the fast-paced world of life sciences product development, regulatory submissions are not just a procedural requirement, they are a cornerstone of asset development and a requirement to getting novel and innovative products ...
At Facet Life Sciences, we understand that the product development landscape is evolving, and one of the key drivers of this evolution is the growing importance of real-world evidence (RWE). It has the potential to accelerate a...
From The Corner Office Q2 2024Ken VanLuvanee, President & CEO Apologies for the delay—this past quarter, we’ve championed a large number of Sponsor-FDA meetings and have had even more informal interactions in our quest to ...
FACET BY THE NUMBERS Total ESG submissions to FDA Apr – June 2024: Over 30! Early-Stage Development Highlights 6 formal FDA meetings, 1 investigator-initiated IND, over 25 IND amendments (e.g., new protocols/amendments, CMC up...
Team Focus – New Facet Team Members We are excited to announce the addition of 3 new team members. Eva Raspor, Strategic Regulatory Writer Facet welcomes Eva Raspor to our team as a Strategic Regulatory Writer. Eva has a...
Facet Donates to SNMMI’s Mars Shot Facet is proud to be a SNMMI Mars Shot Research Fund donor in 2024. The goal of this fund is to improve and extend the lives of patients with cancer through innovation with radiopharmaceutica...
Facet Attends SNMMI In June, Dr. Lisa Jenkins VanLuvanee attended the Society of Nuclear Medicine & Molecular Imaging (SNMMI) annual meeting. SNMMI is an educational, scientific, research, and networking organization focus...
Facet Attends Psychedelic Therapeutics & Drug Development Conference In May, Dr. Jason Mercer attended the Psychedelic Therapeutics & Drug Development Conference. This conference brought together academic and industry ...
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