Zdrowie i gospodarka · 26.08.1996
Single Dose Acute Toxicity Testing for Pharmaceuticals; Revised Guidance; Availability
The Food and Drug Administration (FDA) is publishing a revised guidance entitled ``Single Dose Acute Toxicity Testing for Pharmacueticals.'' This guidance was originally published as part of a proposed implementation document entitled ``U.S. FDA's Proposed Implementation of ICH Safety Working Group Consensus Regarding New Drug Applications.'' The agency has revised the guidance based on comments it received on the proposed implementation document.