By: Lisa VanLuvanee, Ph.D. Expanded access, also known as compassionate use, is a program that allows patients with serious or life-threatening conditions to gain access to investigational drugs, biologics, and medical devices ...
Blogs
Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products
By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory Innovator The world of cellular and gene therapy (CGT) is advancing rapidly, with new technologies offering transformative potential for patients facing serious and rare co...
Understanding the Impact of the 2025 CPT Code Updates on Healthcare Innovation
By Randy Goodman, Ph.D., MHA, FACHE, PMP, BCMAS The American Medical Association (AMA) has officially released the updated Current Procedural Terminology (CPT) codes for 2025. This release marks a significant update reflecting ...
Facet Life Sciences Named Regulatory Partner for Cybin’s Neuropsychiatry Therapeutics Development Pipeline
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...
Why Do You Need a Life Sciences Product Landscape Assessment?
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...
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FDA issued a draft guidance for industry and FDA staff on Chemical Analysis for Biocompatibility Assessment of Medical Devices.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...
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