4 min read
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...
3 min read
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...
3 min read
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...
5 min read
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...
4 min read
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
Learn how our regulatory affairs team was able to work with a sponsor to build a complete, FDA-compliant IND from scratch. Our collaborative efforts led to successful IND submission and initiation of clinical trials with confidence, preventing potential...
4 min read
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
When our sponsor acquired an investigational asset from an international company, they faced a critical regulatory challenge: Could clinical data from foreign trials not conducted under a U.S. IND be included in their New Drug Application? The foreign...
2 min read
In a recent Trailblazers interview, Cindy Henderson, Chief Strategy Officer at Veristat, shared her inspiring career journey from the mailroom to the executive team. Her story is packed with insights for anyone working in clinical research—from clinical...
3 min read
In today’s regulatory climate, ongoing discussion about FDA workload, funding constraints, and shifting review priorities have sparked anxiety across the biopharma industry — especially for sponsors preparing for key submissions like INDs or NDAs. At...