Monthly FDA Guidance and Regulatory News Review - August 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Single-Arm Studies: A Strategic Path to Oncology Drug Approval
In oncology drug development, randomized controlled trials (RCTs) are the gold standard for...
IND Success Strategy: Building a High-Quality IND from Scratch with Strategic Gap Analysis
Learn how our regulatory affairs team was able to work with a sponsor to build a complete,...
Trends in Oncology Regulation: FDA Draft Guidance on OS and Radiopharmaceuticals
Over the past two decades, the FDA has steadily increased the number of guidance documents it...
Monthly FDA Guidance and Regulatory News Review - July 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
NDA Success Strategy: Using Non-US Clinical Data in an NDA Submission
When our sponsor acquired an investigational asset from an international company, they faced a...
On Track and in Sync: How Veristat Continues to Support Efficient FDA Interactions
In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and...
FDA’s Project FrontRunner: A Path Forward for Cancer Drug Development
The FDA’s Oncology Center of Excellence (OCE) is shifting the paradigm in cancer treatment...
Cross-Functional Collaboration: A Cornerstone of Successful Clinical Development
Complex therapeutic development requires deep integration across clinical, regulatory, statistical,...
Monthly FDA Guidance and Regulatory News Review - June 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...