Business · 19/09/2023Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance on Demonstrating Effectiveness of Clinical Investigations
Summary
The FDA is releasing a draft guidance to help pharmaceutical companies demonstrate substantial evidence of effectiveness for their products based on a single, well-controlled clinical investigation and confirmatory evidence, building on previous guidance from 1998 and 2019.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →