DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service
Food and Drug Administration
Rockville MD 20857
DATE: August 13, 2001
TO: Anti-Infective Drugs Advisory Committee Members and Guest Experts
FROM: Leo Chan, Regulatory Project Manager
SUBJECT: Comment on the 1992 Points To Consider Document on Clinical Development And Labeling Of Anti-Infective Drug Products
The enclosed Points to Consider (PTC) document was initially published in 1992, and included advice on the selection of delta on pages 20-21. In February 2001, these two pages were revised, and the approach of basing delta on success rates was no longer used. Attached are both versions of pages 20-21 with the published date marked at the top of the page.
Leo Chan, R.Ph.
Regulatory Project Manger
Division of Special Pathogen and Immunologic Drug Products