DRUG APPROVALS BASED ON ONE PIVOTAL PHASE III TRIAL ARE ELEMENT OF WYDEN REFORM PLAN; FDA HAS SOME REFORMS UNDER WAY, SOME ARE PERENNIAL WYDEN IDEAS
Executive Summary
In an effort to speed clinical trials, FDA should grant drug approvals "on the basis of one pivotal Phase III clinical trial with a sound clinical basis," Rep. Wyden (D-Ore.) suggested in an April 4 letter to President Clinton.