FDA Nonclinical Requirements for Radiopharmaceutical Drugs: Diagnostic vs. Therapeutic Pathways
By Dr. Bill F. Hodnick, DABT If you are developing [...]
Key Challenges with Orphan Drug Development for Rare Disease Treatments
By Lisa Jenkins VanLuvanee, Ph.D. Per the US FDA, orphan [...]
Facet is Proud to be a 2025 SNMMI Mars Shot Research Fund Donor
Facet Life Sciences contributed to and proudly supports the 2025 [...]
Facet Life Sciences Announces Partnership with Nucleus as Official Regulatory Partner
Facet Life Sciences specializes in guiding life science companies through [...]
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 [...]
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