RAC TEST 2 QUESTIONS WITH
CORRECT ANSWERS
Requirements for Reserve Lots of API - Correct Answers -A reserve sample
representative of each lot of each shipment of each active ingredient shall be retained.
2x the amount that would be needed for the testing protocol are needed
Reserve samples need to be stored at labeled conditions
Any deterioration needs to be investigated
Special Control - Correct Answers -Black Box Warning
Not subject to user fee exemption - Correct Answers -Real Time Supplement
Special 510(k) - Correct Answers -A company wants to modify its legally marketed
device in a way that does not affect the device's intended use or alter its
fundamental scientific technology. If the design outputs of the modified device meet the
design input requirements, this
change would be best filed as a(n):
Phase 2 trials - Correct Answers -Conducted to determine the common short-term side
effects and risks associated with the drug.
Treatement IND - Correct Answers -issued as a means of providing eligible subjects
with investigational drugs or biologics for the treatment of serious and life-threatening
illnesses for which there are no suitable alternative treatments. Regulatory Reference:
21 CFR Part 312.83.
Auditor Independence - Correct Answers -The quality assurance manager cannot audit
areas of the quality system for which he/she is responsible. Regulatory Reference: 21
CFR 820.22.
ANDA cannt be expidited because: - Correct Answers -Products that show evidence of
safety and effectiveness in a new subpopulation
Orphan Drug Status - Correct Answers -cannot be requuested once another NDA (non-
orphan) is under reivew for the same indication.
CORRECT ANSWERS
Requirements for Reserve Lots of API - Correct Answers -A reserve sample
representative of each lot of each shipment of each active ingredient shall be retained.
2x the amount that would be needed for the testing protocol are needed
Reserve samples need to be stored at labeled conditions
Any deterioration needs to be investigated
Special Control - Correct Answers -Black Box Warning
Not subject to user fee exemption - Correct Answers -Real Time Supplement
Special 510(k) - Correct Answers -A company wants to modify its legally marketed
device in a way that does not affect the device's intended use or alter its
fundamental scientific technology. If the design outputs of the modified device meet the
design input requirements, this
change would be best filed as a(n):
Phase 2 trials - Correct Answers -Conducted to determine the common short-term side
effects and risks associated with the drug.
Treatement IND - Correct Answers -issued as a means of providing eligible subjects
with investigational drugs or biologics for the treatment of serious and life-threatening
illnesses for which there are no suitable alternative treatments. Regulatory Reference:
21 CFR Part 312.83.
Auditor Independence - Correct Answers -The quality assurance manager cannot audit
areas of the quality system for which he/she is responsible. Regulatory Reference: 21
CFR 820.22.
ANDA cannt be expidited because: - Correct Answers -Products that show evidence of
safety and effectiveness in a new subpopulation
Orphan Drug Status - Correct Answers -cannot be requuested once another NDA (non-
orphan) is under reivew for the same indication.
