On July 15, 2008, the Food and Drug Administration (FDA) published a final rule amending the current good manufacturing practice (CGMP) regulations for human drugs and biological products to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements.  FDA will continue to exercise oversight of the manufacturing of these drugs under FDA’s general statutory CGMP authority and through review of the investigational new drug applications. In addition, FDA is announcing the availability of a guidance document on “CGMP for Phase 1 Investigational Drugs,” which sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs.  FDA is taking this action to focus a manufacturer’s effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational drug products intended for use in phase 1 clinical trials while ensuring safety and quality.  This action will also streamline and promote the drug development process, according to FDA.