Catch up on the latest FDA updates and regulatory news with Facet Life Sciences’ comprehensive FDA Round-Up reports.
Understanding Type B FDA Meetings
A Type B meeting (also called a Milestone Meeting or [...]
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
By: Lisa VanLuvanee, Ph.D. Expanded access, also known as compassionate [...]
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Navigating the FDA’s Draft Guidance on Developing Cellular and Gene Therapy (CGT) Products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 [...]
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FDA issued a draft guidance for industry and FDA staff [...]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 [...]
Director Jeff Shuren, CDRH Retires
On July 23, 2024, Jeff Shuren, Director of the Center [...]
FDA Round Up – Q1 2024
FDA ROUNDUP: FDA Urges Sponsors to Conduct Third Party [...]
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