Business · 15/07/2008Updated: 10/17/2026 · 1 min read

FDA Exempts Most Phase 1 Investigational Drugs from CGMP Requirements

The FDA is amending the current good manufacturing practice (CGMP) regulations for human drugs to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements, aiming to streamline the drug development process and ensure safety and quality.