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2 min read

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 becoming increasingly essential in informing drug development and regulatory decision-making. To develop patient-focused strategies, researchers must gain a...


4 min read

Executing Patient-Focused Drug Development (PFDD)

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

Unleashing Flexibility in a Rare Disease Gene Therapy Clinical Trial

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

Unlock the Secrets of Effective SD File Preparation for FDA Submissions

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...