Business · 15/07/2008
FDA Announces Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs
The Food and Drug Administration (FDA) has released a document providing guidance on applying current good manufacturing practice (CGMP) requirements to the manufacture of investigational new drugs used in phase 1 clinical trials, effective July 2008.
Original source language: Federal Register — Food and Drug AdministrationOpen original release →