"The [FDA's] Parallel Track policy [57 FR 13250] permits wider access to promising new drugs for AIDS/HIV related diseases under a separate "expanded access" protocol that "parallels" the controlled clinical trials that are essential to establish the safety and effectiveness of new drugs. It provides an administrative system that expands the availability of drugs for treating AIDS/HIV. These studies require prospective IRB review and informed consent." (https://www.fda.gov/regulatory-information/search-fda-guidance-documents/treatment-use-investigational-drugs)
Found 1 search result(s) for "parallel track".
2.3 Mark Harrington — The Importance of Activism to the US Response
(HIV/AIDS Research: Its History & Future Meeting)
... cells and changes in CD4 cells from single nuc nucleoside regimens; and to do the parallel track, which was a huge program to allow the second nucleoside ddI (didanosine/Videx, a nucleoside ...
Apr 27, 2021
... cells and changes in CD4 cells from single nuc nucleoside regimens; and to do the parallel track, which was a huge program to allow the second nucleoside ddI (didanosine/Videx, a nucleoside ...
Apr 27, 2021