Monthly FDA Guidance and Regulatory News Review - December 2025
December 2025 capped the year with a robust slate of FDA activity, including multiple final and...
The Science of Simultaneous Submissions: Managing Multiple Regulatory Pathways
Bringing innovative therapies to patients worldwide no longer necessitates sequential engagement...
EU Pharma Package: Key Takeaways for Clinical Evidence & JCA Strategy
Following the political agreement of 11 December 2025 on the EU Pharmaceutical Package, the summary...
Preserving What Matters: How Institutional Knowledge Protects Value Through M&A
Mergers and acquisitions (M&As) are a defining feature of today’s biopharmaceutical landscape. As...
ASH 2025: Interpreting Rapid Change Across Hematology
Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear:...
De-Risking the Neurology IND: Lessons from Early FDA Engagement
Developing therapies for neurological diseases represents one of the most challenging frontiers in...
Monthly FDA Guidance and Regulatory News Review - November 2025
November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates...
The ctDNA Clinical Trial Advantage: Why CRO Work Puts You on the Cutting Edge
In the rapidly evolving field of circulating tumor DNA research, being on the front lines of...
Early Detection vs. Overdiagnosis: The ctDNA Screening Paradox
The promise of circulating tumor DNA for early cancer detection comes with a complex paradox: the...
Monthly FDA Guidance and Regulatory News Review - October 2025
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...