Tag 'real-world data'

A public consultation has been launched on a draft Rare Disease Therapies Regulatory Framework, with comments accepted until 30 July 2026. The proposed framework aims…

U.S. Food and Drug Administration issued a final guidance for industry titled Postapproval Pregnancy Safety Studies on May 8, 2026. The guidance provides recommendations on…

Pharmacovigilance (PV) has traditionally relied on spontaneous reporting systems, clinical trial data, and published literature to monitor the safety of medicinal products. However, the…

The U.S. Food and Drug Administration (FDA) has announced the availability of the final guidance titled “M14 General Principles on Planning, Designing, Analyzing, and Reporting…