FDA on TEA confidentiality
This article was originally published in The Rose Sheet
Executive Summary
Agency will not keep confidential information that is necessary to meet the "material time" and "material extent" requirements of a Time and Extent Application, FDA says in letters to Merck KgaA, BASF and Symrise regarding the firms' respective requests to include enzacamene, octyl triazone and amiloxate in the OTC sunscreen monograph. For example, while FDA agrees to omit some information from each submission prior to putting it on public display, the agency tells BASF that information regarding specific sales, use and pricing data for select countries will not be redacted. The letters respond to specific requests made by each of the companies. FDA released its evaluation of the three TEAs earlier this year (1"The Rose Sheet" July 28, 2003, p. 11). The ingredients are among the first to be announced as eligible for monograph inclusion via the TEA process...