Regulacje i polityka gospodarcza · 30.08.1995

Pharmacology/Toxicology Electronic Submissions Pilot Project

The Food and Drug Administration (FDA) is announcing the Pharmacology/Toxicology (P/T) Electronic Submissions Pilot Project developed by the Center for Drug Evaluation and Research (CDER). This project is intended to increase the efficiency of both the investigational new drug application (IND) and the new drug application (NDA) review processes by providing for the electronic submission of preclinical P/T study reports. CDER is requesting that interested sponsors submit, on a voluntary basis, electronic copies of P/T study reports containing complete text and graphic material for review in word processor format, in addition to paper submissions.