Group C Treatment IND Protocol
Cancer Terms ->
NCI Administrative Concepts ->
Document Type ->
Protocol Generic Term -> Group C Treatment IND Protocol
Group C Treatment IND Protocol Definition
A means for providing compassionate use of investigational agents between the time that an agent has been shown to have anti-tumor activity and the time that drug becomes available on the market. Investigational agents that have been given Group C/Treatment IND designation by the FDA have reproducible efficacy in one or more specific tumor types. Such an agent is likely to alter the pattern of treatment of the disease and can be safely administered by properly trained physicians without specialized supportive care facilities. If a drug meets these criteria CTEP may initiate a formal application to the FDA to authorize Group C distribution for a specific indication. Such approval is not equivalent to formal FDA approval of effectiveness for this indication. Any registered investigator may receive a Group C agent.
Group C Treatment IND Protocol Synonyms
Group C/Treatment IND Protocol, Treatment IND Protocol, Group C
Terms in Group C Treatment IND Protocol category
Copyright © Cancer Terms 2014 All rights reserved. | Terms of Use | Low Carb Foods
No reproduction or republication permitted.