Protection of firms' confidential data stressed by ODE's Alpert in staff meetings.
This article was originally published in The Gray Sheet
Executive Summary
FDA PROTECTION OF FIRMS' CONFIDENTIAL DATA STRESSED by Susan Alpert, director of the Center for Devices and Radiological Health's Office of Device Evaluation, at a series of meetings Dec. 1 with each of ODE's five divisions. Although Alpert apparently did not discuss any specific incidents of improper handling of information, her talks are said to have related to the possible release of confidential material from a manufacturer's file.