Latest Articles

  • Status Of AI Regulation On Drug Development

    As AI capabilities scale, the FDA expects sponsors and their outsourcing partners to treat AI like any other regulated, computerized system that can influence safety, effectiveness, or quality–define the role, document credibility, control the lifecycle, and monitor performance. read more

  • Flexibility as a Core IND Strategy

    With the increasing complexities of current IND programs, it is critical to work with regulatory agencies to seek input early in the process. read more

  • Horizon Lines: A Quarterly Review of NDAs – January-March, 2026

    The NDAs approved during the first quarter of 2026 have been divided into the dosage forms Injection, Tablets, Capsules, Oral solution, Gas, and other. read more

  • The Human Advantage in ADME Testing

    Animal models do not accurately recapitulate several aspects of human physiology, and these differences lead to variations in drug behaviors across species. Each contributes useful evidence, but what is missing is the connected human biology needed to predict ADME behavior with confidence. read more