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

  • Shore to Please

    As this year is coming rapidly to a close, I thought it might be interesting to review the ten biggest announced projects since January: read more

  • Future-Proofing Pharmacovigilance in an AI Era

    Clinical research organizations (CROs) are entering an era in which pharmacovigilance systems are doing more than just tracking copious amounts of data. They must also keep pace with evolving regulations, manage the growing volume of adverse event reports, and respond to heightened scrutiny from both regulators and the public. read more

  • Why DSCSA Compliance in 2026 Hinges on Execution, Not Implementation

    After a decade of ramp-up, the era of DSCSA enforcement is no longer theoretical — it’s here. But as we move deeper into this phase of full compliance, the real story unfolds not just in establishing data feeds, but in the operational cracks that persist behind the scenes. read more