By Lisa Jenkins VanLuvanee, Ph.D. Per the US FDA, orphan drugs address rare diseases affecting fewer than 200,000 people in the United States. Developing these therapies presents challenges beyond typical drug development. The ...
Blogs
Facet is Proud to be a 2025 SNMMI Mars Shot Research Fund Donor
Facet Life Sciences contributed to and proudly supports the 2025 Mars Shot program, a Society of Nuclear Medicine and Molecular Imaging (SNMMI) initiative that provides funding to developers using nuclear medicine to find novel...
Facet Life Sciences Announces Partnership with Nucleus as Official Regulatory Partner
Facet Life Sciences specializes in guiding life science companies through the complex journey of drug, biologic, and medical device development and registration with the US FDA. Facet is pleased to announce the company’s role a...
Navigating Pre-IND Meetings: A Strategic Guide
When developing a new drug, early engagement with FDA through a Pre-Investigational New Drug (Pre-IND) meeting can set the stage for a smoother regulatory process. This meeting is essential to avoid clinical holds and prevent c...
Navigating the Pre-BLA Meeting Process: Securing a Clear Pathway to Success
Preparing for a Pre-Biologics License Application (Pre-BLA) meeting with FDA is a pivotal step in the regulatory journey for sponsors seeking to bring a biologic product to market. This meeting provides an invaluable opportunit...
Understanding FDA Type A Meetings: Purpose, Process, and Key Considerations
For life sciences companies navigating the FDA regulatory landscape, Type A meetings are generally considered informative meetings focused on resolving issues. They primarily apply to the drug and biologic development process u...
FDA Type D Meetings: A New Option for Targeted, Time-Sensitive Regulatory Guidance
Effective communication with FDA through various FDA meetings is essential for a smooth and efficient drug development process. While Type A, B, and C meetings have long been established as key regulatory meeting types, FDA int...
Understanding Type C FDA Meetings: A Flexible Forum for Regulatory Guidance
When developing a new drug or biologic, timely and strategic engagement with FDA can be the key to a smoother regulatory pathway. While Type A and Type B meetings are often tied to critical milestones, Type C meetings serve as ...
Understanding Type B FDA Meetings
A Type B meeting (also called a Milestone Meeting or an Entitled Meeting) is a formal meeting between the sponsor and FDA to discuss product development and next steps. These meetings are crucial to keep product development mov...
What are the Different FDA Meeting Types for Drugs and Biologics?
Communication with FDA when developing innovative pharmaceuticals and biologics is a key driver of success. Early and ongoing engagement with FDA can streamline development, reduce risks, and ensure that a company’s regul...
Expanded Access & Compassionate Use: FDA Guidelines & Key Facts
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 ...
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...
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