Latest Articles

  • 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 – April to June 2026

    This quarterly review on New Drug Applications contains data for applications approved for the first time during the second quarter of 2026, which includes New Molecular Entities (NMEs) and new biologics. read more

  • The Next Test for AI in Pharmacovigilance Is Trust, Not Accuracy

    An AI model can be right and still not be trusted. That’s what Bristol Myers Squibb (BMS) found six months into rolling out AI-powered adverse event processing: while F1 performance scores were tracking upward, the audit trail found reviewers still reopening cases the system had already cleared. read more

  • Beyond Case Management

    In large pharma, a staggering 40 to 50 percent of expert pharmacovigilance time is still consumed by tasks far removed from active, scientific PV - such as the mechanics of scheduling reports, tracking down contributors, and managing documents. read more