Zdrowie i gospodarka · 29/10/2009

FDA Amends IND Regulations to Clarify Address for Bioavailability and Bioequivalence Studies

The Food and Drug Administration (FDA) is updating its regulations to provide a specific address for submitting Investigational New Drug Applications (INDs) for in vivo bioavailability and bioequivalence studies in humans, with the goal of improving accuracy and clarity in the agency's rules.