The U.S. Food and Drug Administration (FDA) has unveiled Elsa, a generative Artificial Intelligence (AI) tool designed to enhance efficiency across its operations, including scientific reviews, inspections, and regulatory processes. This marks a significant step in modernizing the agency’s workflow and leveraging AI to better serve the American public. Why Did the FDA Develop Elsa? The …
Swissmedic has recently introduced updates to the Periodic Safety Update Report (PSUR) and Periodic Benefit-Risk Evaluation Report (PBRER) form for human medicinal products. These revisions aim to enhance clarity, improve regulatory compliance, and streamline the submission process for marketing authorization holders. Key Changes in the Updated Form Implications for Marketing …
READUS-PV stands for: REporting of A Disproportionality analysis for drUg Safety signal detection using individual case safety reports in PharmacoVigilance READUS-PV mainly developed to Standardize the reporting of Disproportionality analysis (DA) used for drug safety signal detection based on individual case safety reports (ICSRs) in pharmacovigilance. Disproportionality analysis is a signal detection …
