Blog | Veristat

4 min read

The Science of Simultaneous Submissions: Managing Multiple Regulatory Pathways

Bringing innovative therapies to patients worldwide no longer necessitates sequential engagement with regulatory agencies. The U.S. Food and Drug Administration (FDA), the European Medicines Agency (EMA), Health Canada, and Japan’s Pharmaceuticals and...

4 min read

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 below highlights the elements most relevant to clinical evidence generation and Joint Clinical Assessment (JCA) planning. This reform represents the most...

4 min read

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 companies merge pipelines, teams, and strategies, clinical development programs often undergo significant transitions. Yet during these shifts, one of the...

4 min read

ASH 2025: Interpreting Rapid Change Across Hematology

Returning from the American Society of Hematology Annual Meeting in Orlando, one message was clear: hematology is entering a phase of rapid diversification. Across late-breaking abstracts, plenary sessions, and maturing follow-up data, ASH 2025 reflected...

2 min read

De-Risking the Neurology IND: Lessons from Early FDA Engagement

Developing therapies for neurological diseases represents one of the most challenging frontiers in modern biotechnology. With subjective clinical assessments, high variability in outcomes, and substantial investment requirements, neurology programs face...

3 min read

Monthly FDA Guidance and Regulatory News Review - November 2025

November brought significant FDA activity, with new final and draft guidances—from Pre-RFD updates to cross-center master files and Q3E leachables—alongside notable RAPS coverage, leadership changes, regulatory developments, and multiple high-impact drug...

4 min read

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 clinical trials offers unparalleled insights into the future of cancer care. As Dr. Gabriela Rosu, Veristat’s Vice President, Global Medical Affairs, observes,...

4 min read

Early Detection vs. Overdiagnosis: The ctDNA Screening Paradox

The promise of circulating tumor DNA for early cancer detection comes with a complex paradox: the very sensitivity that makes ctDNA valuable for catching cancer early also raises concerns about overdiagnosis and overtreatment. As Dr. Gabriela Rosu,...

3 min read

Monthly FDA Guidance and Regulatory News Review - October 2025

Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance updates from the US Food & Drug Administration (FDA) that are pertinent to the governance of clinical trials and drug, biologic, or medical device development...

1 min read

Accelerate Neurology/Psychiatry Trial Success with Expert Guidance

Learn how our neuroscience team partner with sponsors across multiple therapeutic areas to accelerate trial success in complex neurological and psychiatric conditions. Our collaborative efforts have supported successful marketing applications,...