FDA PHARMACOLOGY/TOXICOLOGY REVIEWS AT IND EARLY-STAGE SHOULD BE DE-EMPHASIZED, FORMER CDER SENIOR OFFICIAL MEYER SUGGESTS; IND DEREGULATION HAS "MERIT"
Executive Summary
FDA should "back away from" some of the pharmacology and toxicology requirements "at the early stages of the IND" review process, former Center for Drug Evaluation & Research Deputy Director Gerald Meyer, MD, suggested at a Feb. 1 ACIL Life Sciences Forum in Arlington, Va.