Rivulet Media Inc (fka RIVU)

[yaadmon]

pg.4 Investigational New Drug (IND) Application
Except under very limited circumstances, FDA requires data from clinical trials—formally
designed, conducted, and analyzed studies of human subjects—to provide evidence of a drug’s
safety and effectiveness. Before testing in humans—called clinical testing—the drug’s sponsor
(usually its manufacturer) must file an investigational new drug (IND) application with FDA. The
IND includes information about the proposed clinical study design, completed animal test data,
and the lead investigator’s qualifications. It must also include the written approval of an
Institutional Review Board, which has determined that the study participants will be made aware
of the drug’s investigative status and that any risk of harm will be necessary, explained, and
minimized. The application must include an “Indication for Use” section that describes what the
drug does and the clinical condition and population for which the manufacturer intends its use.
Trial subjects should be representative of that population. The FDA has 30 days to review an IND
application. Unless FDA objects, a manufacturer may then begin clinical testing. Clinical Trials
With IND status, researchers test in a small number of human volunteers the safety they had
demonstrated in animals. These trials, called Phase I clinical trials, attempt, in FDA’s words, “to
determine dosing, document how a drug is metabolized and excreted, and identify acute side
effects.” If the sponsor considers the product still worthy of investment, it continues with Phase II
and Phase III clinical trials. Those trials gather evidence of the drug’s efficacy and effectiveness
in larger groups of individuals with the particular characteristic, condition, or disease of interest,
while continuing to monitor safet http://www.fas.org/sgp/crs/misc/R41983.pdf