Investigational New Drug Applications; Proposed Amendment to Clinical Hold Regulations for Products Intended for Life-Threatening Diseases

The Food and Drug Administration (FDA) is proposing to amend the provisions of its regulations governing investigational new drug applications (IND's) to permit FDA to place a clinical hold on one or more studies under an IND involving a drug that is intended to treat a life-threatening disease affecting both genders if men or women with reproductive potential who have the disease and are otherwise eligible but are excluded from participation in an investigation only because of a risk or potential risk of reproductive or developmental toxicity from use of the investigational drug. Women have been excluded in the past from early clinical trials because of a risk or potential risk of reproductive or developmental toxicity. Therefore, the primary goal of this proposed amendment is to ensure that women with reproductive potential who have a life-threatening disease are not automatically excluded in the future for that reason. The proposed rule would not impose requirements to enroll or recruit a specific number of men or women with reproductive potential. The proposal would implement a recommendation of both the National Task Force on AIDS Drug Development (the AIDS Task Force) and the Presidential Advisory Council on Human Immunodeficiency Virus/Acquired Immune Deficiency Syndrome (HIV/AIDS).