Navigating Pre-IND Meetings: A Strategic Guide
When developing a new drug, early engagement with FDA through [...]
Navigating the Pre-BLA Meeting Process: Securing a Clear Pathway to Success
Preparing for a Pre-Biologics License Application (Pre-BLA) meeting with FDA [...]
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 [...]
Understanding Type C FDA Meetings: A Flexible Forum for Regulatory Guidance
When developing a new drug or biologic, timely and strategic [...]
Understanding Type B FDA Meetings
A Type B meeting (also called a Milestone Meeting or [...]
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 [...]
Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products
By Dr. Jason Mercer, Ph. D., RAC, Strategic Regulatory Innovator [...]
Understanding the Impact of the 2025 CPT Code Updates on Healthcare Innovation
Announcing the New CPT Code Set for 2025 By Randy [...]
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