AIDS task force

WASHINGTON - The FDA plans to amend its regulations governing INDs and NDAs to require additional gender analysis, FDA Commissioner David Kessler said last week at a meeting of the National Task Force on AIDS Drug Development (NTFADD).

The task force made several recommendations designed to force drug developers to report on the number of women in early clinical trials and prevent the unnecessary exclusion of women from such trials. Kessler said the changes recommended by the task force would be submitted to the Office of Management and Budget within a month.

Gender analysis

Clinical trial sponsors would have to file a gender accrual analysis in annual INDs. In addition, for NDAs and PLAs, the regulations would require sponsors to analyze clinical data by gender and assess potential differences between genders.