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...
Blogs
New Draft FDA Guidance: Chemical Analysis for Biocompatibility Assessment of Medical Devices (September 20, 2024)
FDA issued a draft guidance for industry and FDA staff on Chemical Analysis for Biocompatibility Assessment of Medical Devices.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...
New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)
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...
Strong Regulatory Leadership Guidance in Streamlining Product Development
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 ...
The Growing Importance of Real-World Evidence in Product Development
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...
Facet Life Sciences Quarterly Update Q2 – 2024
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 – Q2 2024
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...
Go Team! – Q2 2024
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...
ICYMI – Q2 2024 – SNMMI’s Mars Shot
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...
ICYMI – Q2 2024 – SNMMI
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...
ICYMI – Q2 2024 – Psychedelic Therapeutics & Drug Development Conference
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 ...
ICYMI – Q2 2024 – Market Access Society of America Symposium
Facet Attends the Market Access Society of America Symposium Dr. Randy Goodman attended the May 21st Market Access Society of America Symposium. This global conference brings together government and industry experts, researche...
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