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In 2022, the FDA’s Center for Drug Evaluation and Research (CDER) launched the Accelerating Rare disease Cures (ARC) Program to help bridge the gap between the urgent needs of patients and the complexities of rare disease drug development.
ARC’s mission...
2 min read
In the intricate world of pharmaceuticals and biotechnology, every step of drug development is meticulously scrutinized by regulatory bodies. For small to medium-sized companies in the field, the journey can be fraught with challenges, especially in...
2 min read
As the industry continues to adopt a patient-centric approach, the use of real-world data is becoming increasingly essential in informing drug development and regulatory decision-making. To develop patient-focused strategies, researchers must gain a...
4 min read
Veristat’s Science Advisory Board met on 14 March 2023 to discuss Executing Patient-Focused Drug Development (PFDD), with a focus on the application in rare diseases.
Patient health and wellness extend beyond biology and symptoms of disease, encompassing...
2 min read
In the world of biotechnology, where groundbreaking discoveries have the potential to change lives, adaptability and flexibility are paramount. Clinical operations can be a complex web of challenges, especially when dealing with rare diseases and gene...
1 min read
In today's world where digital transformation is reshaping industries, even the pharmaceutical sector is not immune to regulatory compliance. The FDA approval process has become significantly streamlined with the introduction of electronic record...