Business · 15/03/2019Updated: 10/17/2026 · 1 min read
FDA Announces Draft Guidance for Industry on Risk-Based Approach to Monitoring Clinical Investigations
Summary
The FDA has released a draft guidance for industry on risk-based monitoring of clinical investigations, building on its 2013 RBM Guidance to provide additional guidance for sponsors to implement risk-based monitoring.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →