Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations
For life sciences companies navigating the FDA regulatory landscape, Type [...]
FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance
Effective communication with FDA through various FDA meetings is essential [...]
Expanded Access & Compassionate Use: FDA Guidelines & Key Facts
Expanded access, also known as compassionate use, is a program [...]
What are the Different FDA Meeting Types for Drugs and Biologics?
Communication with FDA when developing innovative pharmaceuticals and biologics is [...]
Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products
By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory Innovator [...]
Why Do You Need a Life Sciences Product Landscape Assessment?
A life sciences product landscape assessment - also known as [...]
What Is a Value Dossier and Why Do Life Sciences Developers Need One
A value dossier is a critical, strategic tool that outlines [...]
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 [...]
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