What are the Different FDA Meeting Types for Drugs and Biologics?
Communication with FDA when developing innovative pharmaceuticals and biologics is [...]
Expanded Access & Compassionate Use: FDA Guidelines & Key Facts
By: Lisa VanLuvanee, Ph.D.Expanded access, also known as compassionate use, [...]
Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products
By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory InnovatorThe [...]
Understanding the Impact of the 2025 CPT Code Updates on Healthcare Innovation
By Randy Goodman, Ph.D., MHA, FACHE, PMP, BCMASThe American Medical [...]
Facet Life Sciences Named Regulatory Partner for Cybin’s Neuropsychiatry Therapeutics Development Pipeline
Facet Life Sciences, a leader in US regulatory strategy and [...]
Why Do You Need a Life Sciences Product Landscape Assessment?
A life sciences product landscape assessment - also known [...]
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FDA issued a draft guidance for industry and FDA staff [...]
New FDA Guidance: Control of Nitrosamine Impurities in Human Drugs (September 2024)
FDA issued Revision 2 of the guidance for industry Control [...]
Strong Regulatory Leadership Guidance in Streamlining Product Development
In the fast-paced world of life sciences product development, regulatory [...]
The Growing Importance of Real-World Evidence in Product Development
At Facet Life Sciences, we understand that the product development [...]
gET sOCIAL