FDA CDER’s Accelerating Rare disease Cures (ARC) Program
In 2022, the FDA’s Center for Drug Evaluation and Research (CDER) launched the Accelerating Rare...
Regulatory Guidance Monthly Review - November 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Navigating Regulatory Challenges in Biologics: A Case Study in Overcoming Clinical Holds
In the intricate world of pharmaceuticals and biotechnology, every step of drug development is...
FDA Guidance Series on Patient-Focused Drug Development (PFDD) to Enhance Product Development and Regulatory Decision Making
As the industry continues to adopt a patient-centric approach, the use of real-world data is...
Regulatory Guidance Monthly Review - October 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Positioning a Sponsor’s First Trial for Success: A Comprehensive Planning Approach for Cancer Antibody
Clinical trials require meticulous planning and strategic guidance for success. In this case study,...
Executing Patient-Focused Drug Development (PFDD)
Veristat’s Science Advisory Board met on 14 March 2023 to discuss Executing Patient-Focused Drug...
Regulatory Guidance Monthly Review - September 2023
Each month, Veristat's regulatory team tracks and shares a selection of new Regulatory Guidance...
Unleashing Flexibility in a Rare Disease Gene Therapy Clinical Trial
In the world of biotechnology, where groundbreaking discoveries have the potential to change lives,...
Natural History Study Best Practices for Engaging Regulatory Authorities
When seeking guidance from the FDA, EMA, or other regulatory agencies regarding the inclusion of a...