Business · 17/01/2006Updated: 10/17/2026 · 1 min read
FDA Releases Draft Guidance for Industry on Investigational New Drugs and Good Manufacturing Practice
Summary
The Food and Drug Administration (FDA) has published a draft guidance to help pharmaceutical companies comply with Good Manufacturing Practice (CGMP) regulations during Phase 1 clinical trials, a process aimed at ensuring the safety of trial participants.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →