Module 7 Investigational New Drugs (IND) Flashcards
Investigational New Drugs (IND)
An investigational new drug includes (3)
- new drugs
- new biological drugs
- biological products used in vitro for diagnostic purposes.
An investigator proposes to study a marketed drug sold to treat high BP. The drug is approved for adults, but the investigator proposes to study the drug with individuals over age 12. The manufacturer is supplying the drug and hopes that the information from the research can be used to change the labeling for use of the drug in children. What is the investigator’s most appropriate course of action
Submit an IND application to the FDA and obtain IRB approval.
What is an acceptable criteria for determining a study of an approved drug does not require an IND?
The study is not intended to be reported to FDA to support a new indication or support a labeling change.
An IND contains information in the following areas (4)
- animal pharm & toxicology
- previous experience with the drug in humans
- manufacturing info
- clinical protocols and investigator info.
An investigational new drug application cover page is form___
Form FDA 1571
T/F
A sponsor can include that an investigational new drug is safe and effective on the labeling
FALSE
When does an IND go into effect
30 days after the FDA receives the IND. Unless the FDA notifies the sponsor of a clinical hold.
T/F
Whenever a sponsor intends to conduct a study that is not covered by a protocol already contained in the IND the sponsor must submit a protocol amendment to the FDA
TRUE
T/F
When a new investigator is added to carry out a previously submitted protocol, is the sponsor required to submit a protocol amendment to the FDA
TRUE
When should the FDA be notified of an unexpected fatal or life-threatening suspected adverse reaction
7 calendar days
What is the difference between emergency use of a test article and non-emergent expanded access (compassionate use)?
Whether or not there is time to obtain IRB review prior to administration of test article
An investigator is confronted with a life-threatening situation that necessitates using a test article in a human subject who is unable to provide informed consent and there is no time to obtain consent for the individual’s LAR. Under FDA regulations, which action should the investigator take?
The investigator and another physician not part of the study team agree that the situation necessitates the use of the test article, and the IRB will be notified later.
T/F
During the IND application, the only data that is submitted is data gathered from human clinical trials.
FALSE
GS-US-312-0118
A phase, randomized, open-label study evaluating the efficacy and safety of Idelalisib in combination with obinutuzumab compared to chlorambucil in combination with obinutuzumab for previously untreated CLL is what PHASE?
PHASE 3
T/F
Use of a marketed drug off label in the course of medical practice is considered a clinical investigation
FALSE
