Zdrowie i gospodarka · 27.01.2003
Nonclinical Datasets; Notice of Pilot Project
The Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER), is seeking volunteers to participate in a pilot project involving the evaluation of various analysis tools to facilitate the use of electronic datasets for analysis of animal data submitted to FDA by applicants of new drug applications (NDAs). These analysis tools will allow a reviewer to more efficiently display and evaluate nonclinical datasets submitted in electronic format.