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...
Blogs
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Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products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...
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 ...
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