The HIV/AIDS vaccine researchers' orientation to the process of preparing a US FDA application for an investigational new drug (IND): what it is all about and how you start by preparing for your pre-IND meeting
Vaccine. 2002 Jan 31;20(9-10):1261-80.
doi: 10.1016/s0264-410x(01)00453-4.
1 Vaccine and Prevention Research Program, Division of AIDS, National Institute of Allergy and Infectious Diseases, 6700-B Rockledge Dr., Room 4108, Bethesda, MD 20892-7628, USA. sshapiro@niaid.nih.gov