FDA GOOD REVIEW PRACTICES COMMITTEE WILL INITIATE "ACTION PLAN"

Executive Summary

FDA GOOD REVIEW PRACTICES COMMITTEE WILL INITIATE "ACTION PLAN" at a break-out meeting set for Nov. 21, a Nov. 3 summary of the GRP initiative prepared by Office of Drug Evaluation I Director Temple and special assistant to the Center for Drug Evaluation and Research Director Jeffrey Yorke states. The meeting will also feature discussion of "the results of the initial workshops" and will "solicit input on the project from staff involved in the review of INDs, NDAs, and PLAs," the summary notes.