2/27/2008
As provided in section 1107 of Title 10, United States Code, an FDA-approved drug or biological product administered for a use not described in the approved labeling of the drug or biological product (referred to in subsection (g)(2)) and for which requirements of use authorization (referred to in subsection (d)(4)) and prior informed consent (referred to in subsection (f)(1)) are applicable by reason of a determination (referred to in subsection (f)(2)) by the Commissioner of Food and Drugs that such use is subject to the investigational new drug requirements of section 505(i) of the Federal Food Drug and Cosmetic Act (FFDCA) (21 U.S.C. 301, et seq.).
DHA Address: 7700 Arlington Boulevard | Suite 5101 | Falls Church, VA | 22042-5101
The appearance of hyperlinks does not constitute endorsement by the Defense Health Agency of non-U.S. Government sites or the information, products, or services contained therein. Although the Defense Health Agency may or may not use these sites as additional distribution channels for Department of Defense information, it does not exercise editorial control over all of the information that you may find at these locations. Such links are provided consistent with the stated purpose of this website.