Accessibility to New Drugs for Use in Military and Civilian Exigencies When Traditional Human Efficacy Studies Are Not Feasible; Determination Under the Interim Rule That Informed Consent Is Not Feasible for Military Exigencies; Request for Comments

摘要

The Food and Drug Administration (FDA) is requesting written comments related to the advisability of revoking or amending the interim final rule that permitted the Commissioner of Food and Drugs (the Commissioner) to determine that obtaining informed consent from military personnel for the use of an investigational drug or biologic is not feasible in certain situations related to military combat. The agency is also soliciting written comments identifying the evidence needed to demonstrate safety and effectiveness for such investigational drugs that cannot ethically be tested on humans for purposes of determining their efficacy. FDA is seeking written comments from all interested parties, including, but not limited to: Consumers, patient groups, veterans and veteran groups, active-duty military personnel, organizations and departments, ethicists, scientists, researchers with particular expertise in this area, and health care professionals. The written comments are intended to provide FDA with information to help the agency in making policy decisions on the use of investigational products during military exigencies and the appropriate evidence needed to demonstrate safety and effecti