Standards of clinical investigations in the USA.
The drug approval process in the USA is underconstant surveillance, monitoring and evaluation.
Several significant changes were made during the past few years and many others are under consideration.
The FDA has undergone organizational changes, which together with the IND Rewrite and NDA Rewrite resulted in a shift of emphasis in clinical studies.
Mots-clés Pascal : Exploration clinique, Médicament, Etats Unis, Amérique du Nord, Amérique, Essai clinique, Législation, Organisation
Mots-clés Pascal anglais : Clinical investigation, Drug, United States, North America, America, Clinical trial, Legislation, Organization
Notice produite par :
Inist-CNRS - Institut de l'Information Scientifique et Technique
Cote : 93-0478587
Code Inist : 002B02A. Création : 199406.