Transparent timing
This article was originally published in Pharmaceutical Approvals Monthly
Executive Summary
Industry should have a better idea by the end of February regarding just how far FDA might go in releasing information in "complete response" letters, withdrawn applications and other material associated with drug applications that currently is withheld from the public, FDA Principal Deputy Commissioner Joshua Sharfstein indicated Jan. 12. Sharfstein was unveiling the first part of FDA's transparency initiative, a public Web site with basic information, but he reported the second phase, "about what information does FDA have in its possession and now is not accessible, what information will we make accessible," will follow shortly. A third phase of the transparency initiative will address industry desires to obtain clarification about ambiguous rules and more information on the basis for agency decisions (1"The Pink Sheet" DAILY, Nov. 13, 2009). The transparency task force, headed by Sharfstein, will recommend to Commissioner Margaret Hamburg which information can be released while still protecting confidentiality. The recommendations will be made available for public comment before Hamburg decides on a final plan of action