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Multi-Regional Clinical Trials: The Latest Guidance from FDA
Planning and designing clinical trials conducted in multiple geographic or regulatory regions
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Regulatory Submissions (2)
3 min read
Monthly FDA Guidance and Regulatory News Review - December 2024
January 14, 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...
3 min read
Monthly FDA Guidance and Regulatory News Review - November 2024
December 15, 2024
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...
3 min read
Monthly FDA Guidance and Regulatory News Review-October 2024
November 13, 2024
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
Monthly FDA Guidance and Regulatory News Review-September 2024
October 16, 2024
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...
Successful DMC Services for Complex Hematologic Cancer Trial
October 10, 2024
Learn how Veristat's expert biostatistics team worked with a longstanding global biopharma sponsor to navigate complex Data Monitoring Committee (DMC) requirements for a challenging hematologic cancer trial. Collaborative efforts led to successful trial...
Understanding the Critical Role of Data Monitoring Committees in Clinical Trials
October 4, 2024
Learn how Veristat's expert teams develop and organize various independent Data Monitoring Committees (DMCs) to ensure patient safety and trial integrity. Discover the crucial role DMCs play in monitoring trial conduct, assessing risks and benefits, and...
4 min read
Monthly FDA Guidance and Regulatory News Review - August 2024
September 16, 2024
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...
3 min read
FDA’s Draft Guidance for Data Monitoring Committees (DMCs)
August 28, 2024
How Veristat’s Proven DMC Expertise for Complex Trials Supports Patient Safety and Sponsor Success
4 min read
Monthly FDA Guidance and Regulatory News Review - July 2024
August 28, 2024
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...