Zdrowie i gospodarka · 13/08/2009

FDA Expands Access to Investigational Drugs for Treatment Use

The US Food and Drug Administration (FDA) has amended its regulations to expand access to investigational new drugs for treatment use, particularly for patients with serious or life-threatening conditions who lack other therapeutic options. The final rule clarifies existing regulations and introduces new expanded access categories for individual patients, intermediate-size populations, and larger populations under treatment protocols.