FDA authority to suspend trials barring women of childbearing potential recommended by AIDS task force.
Executive Summary
FDA AUTHORITY TO HALT TRIALS EXCLUDING WOMEN PROPOSED in a draft recommendation by the National Task Force on AIDS Drug Development at its Jan. 19 meeting. FDA regs would be amended to provide the agency with the authority to place a clinical hold on trials involving drugs for life-threatening diseases if the sponsor is determined to be excluding women when there is no evidence of reproductive toxicity. If the exclusion continued, FDA would have the authority to terminate the sponsor's IND.