ComplianceOnline

How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

  • By: Staff Editor
  • Date: February 20, 2017
  • Source: http://www.fda.gov
Abstract:

How to Comply with FDA cGMP Requirements for Phase 1 Investigational Drugs?

The phase I of a clinical trial involves the initial introduction of the investigational new drug (IND) into the human beings. Consequently, it is important to regulate these studies to ensure patient safety. The FDA guidance outlines the current good manufacturing practices (cGMP) for most of the investigational drugs used in phase 1 clinical trials.

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