Gender data rules; PTO hearing on patent terms

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

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