Zdrowie i gospodarka · 17/01/2006

FDA Exempts Most Phase 1 Investigational Drugs from CGMP Regulations

The US Food and Drug Administration (FDA) is amending its current good manufacturing practice (CGMP) regulations to exempt most Phase 1 investigational drugs from complying with the requirements, instead exercising oversight under its general statutory CGMP authority and investigational new drug application (IND) authority.