Week 1-5 Review
Amoxicillin is an example of what?
What is a drug?
How many phases are in a clinical trial?
What is Four?
A list of approved drugs is found where?
What is the FDA Orange Book?
Phase 4 studies are also known as this
What are Post marketing studies?
What is Risk Evaluation and Mitigation Strategies?
What is the Durham-Humphrey Amendment?
What is an IRB (Institutional Review Board)?
An adverse event that resulted in a congenital anomaly is known as
This is required before dispensing Clozapine
What is blood work?
This individual takes responsibility of initiating, managing and funding a clinical trial and also conducts/oversees the trial.
What is a sponsor-investigator?
How long must records be retained in a clinical trial?
What is 2 years after the marketing application is approved?
ICON is an example of what?
This amendment gave the FDA further authority to require post market studies to assess risks related to using the drug
What is the FDAAA (FDA Amendment Act)?
This individual develops the REMS program
This form is a the cover sheet for an INDA and is required for each application.
What is a Form 1571?
What is the regulatory office for animal research called?
The FDA sent notice to Purell for misbranding their product as a drug. This notice is known as:
What is a Warning Letter?
Where does the FDA release post marketing safety data?
What is FAERS (FDA Adverse Event Reporting System)?
What is a medication guide?
Remdesivir, used for the treatment of COVID-19, is what kind of IND?
What is the Partners IRB called?
What is the Partners Human Research Committee (PHRC)?
If an investigator fabriates data, where can their case be found?
What is the Office of Research Integrity?
The sponsor has how many days to report safety data to the FDA?
This is an individual who identifies clinical investigators, communicate medical/scientific data, provide training and support clinical research terms.
What is a Medical Science Liason?