Some Phase I Drugs May Be Exempt From GMP Requirements

International Pharmaceutical Regulatory Monitor
A A
After withdrawing a final rule more than two years ago to exempt investigational drugs in Phase I testing from certain good manufacturing practice (GMP) regulations, the U.S. Food and Drug Administration (FDA) is issuing another final rule that will do just that.

To View This Article:

Login

Subscribe To International Pharmaceutical Regulatory Monitor

Buy This Article Now

Add this article to your cart for $20.00