FDA to require inclusion of women of childbearing potential in clinical studies -- proposed rule.

FDA CLINICAL HOLD USE TO ENSURE INCLUSION OF WOMEN OF REPRODUCTIVE POTENTIAL would be established by a proposed rule published by FDA in the Federal Register Sept. 24. The rule would allow FDA to issue a clinical hold if a proposed or ongoing Phase I-III trial or expanded use program for a therapy for a life-threatening disease excludes young women. "FDA will generally attempt to discuss and satisfactorily resolve the matter with the sponsor before issuing the clinical hold order," the proposed rule states. "An IND would be placed on clinical hold for specifically excluding women with reproductive potential only as a last resort."