US RAC Exam Prep Exam Questions and Answers with Verified
Solutions | Latest 2026 Update
Q: 30-day hold
Answer:
(aka 30-day safety review) Time frame between filing a protocol under an IND and
the FDA approval to proceed with enrollment. Also, the time period between when
a company submits an IND and when it can initiate a protocol. This timeline may
be extended if FDA does not agree with the proposed protocol. (see "Clinical
Hold.")
Q: 120-day Safety Report
Answer:
Amendment to an NDA containing a safety update due 120 days after the NDA is
filed.
Q: 180-day Exclusivity
Answer:
Protects an ANDA applicant from competition from subsequent generic versions
of the same drug for 180 days.
Q: 505(b)(2) Application
Answer:
An application submitted under section 505(b)(2) of the FD&C Act for a drug for
which one or more of the investigations relied on by the applicant for approval of
the "application were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
Q: Traditional 510(k)
Answer:
A premarket notification (PMN) submitted to FDA to demonstrate that the medical
device to be marketed is safe and effective or "substantially equivalent" to a legally
marketed device. 510(k) refers to the section of the FD&C Act authorizing the
submission of the premarket notification. FDA processing time is 90 days.
,Q: Special 510(k)
Answer:
For use where device modifications neither affect the intended use nor alter its
fundamental scientific technology. FDA processing time is 30 days.
Q: Abbreviated 510(k)
Answer:
A type of 510(k) submission that is supported by conformance with guidance
document(s), special controls or standards. FDA processing time is 90 days.
Q: 515 Program Initiative
Answer:
Created to facilitate reclassification action on the remaining pre-amendments Class
III 510(k)s.
Q: Accelerated Approval
Answer:
Allows earlier approval of drugs to treat serious diseases and those that fill an
unmet medical need based on a surrogate endpoint.
Q: Action Letter
Answer:
Official communication from FDA informing an NDA or BLA sponsor of an
agency decision; includes approvable, not approvable and clinical hold.
Q: ADME
Answer:
Absorption, Distribution, Metabolism and Excretion
Q: Adulterated
Answer:
Product containing any filthy, putrid or decomposed substance; or prepared under
unsanitary conditions; or not made according to GMPs; or containing an unsafe
color additive; or does not meet the requirements of an official compendium
(FD&C Act, SEC. 501 [351])
, Q: Advisory Committee
Answer:
Committees and panels used by FDA to obtain independent expert advice on
scientific, technical and policy matters.
Q: ANDA
Answer:
Abbreviated New Drug Application. Used for generic drugs. Found in 21 CFR
314.92 and 505(j) of the FD&C Act. Are not required to include animal safety and
clinical data to demonstrate safety and efficacy, but for oral dosages forms must
scientifically demonstrate that the drug is bioequivalent to the Reference Listed
Drug (RLD). CMC (Chemistry, Manufacturing and Controls) is required.
Q: Annual Report
Answer:
An annual periodic report or progress report that must be submitted to FDA.
Depending on the type of application for which the report is submitted, it may
include new safety, efficacy and labeling information; preclinical and clinical
investigation summaries; CMC updates; nonclinical laboratory studies; and
completed unpublished clinical trials
Q: Approved
Answer:
FDA designation given to drugs, biologics and medical devices that have been
granted marketing approval
Q: Banned Device
Answer:
Device presenting a substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
Q: BIMO
Answer:
Bioresearch Monitoring Program
Q: Bioequivalence
Solutions | Latest 2026 Update
Q: 30-day hold
Answer:
(aka 30-day safety review) Time frame between filing a protocol under an IND and
the FDA approval to proceed with enrollment. Also, the time period between when
a company submits an IND and when it can initiate a protocol. This timeline may
be extended if FDA does not agree with the proposed protocol. (see "Clinical
Hold.")
Q: 120-day Safety Report
Answer:
Amendment to an NDA containing a safety update due 120 days after the NDA is
filed.
Q: 180-day Exclusivity
Answer:
Protects an ANDA applicant from competition from subsequent generic versions
of the same drug for 180 days.
Q: 505(b)(2) Application
Answer:
An application submitted under section 505(b)(2) of the FD&C Act for a drug for
which one or more of the investigations relied on by the applicant for approval of
the "application were not conducted by or for the applicant and for which the
applicant has not obtained a right of reference or use from the person by or for
whom the investigations were conducted" (21 U.S.C. 355(b)(2)).
Q: Traditional 510(k)
Answer:
A premarket notification (PMN) submitted to FDA to demonstrate that the medical
device to be marketed is safe and effective or "substantially equivalent" to a legally
marketed device. 510(k) refers to the section of the FD&C Act authorizing the
submission of the premarket notification. FDA processing time is 90 days.
,Q: Special 510(k)
Answer:
For use where device modifications neither affect the intended use nor alter its
fundamental scientific technology. FDA processing time is 30 days.
Q: Abbreviated 510(k)
Answer:
A type of 510(k) submission that is supported by conformance with guidance
document(s), special controls or standards. FDA processing time is 90 days.
Q: 515 Program Initiative
Answer:
Created to facilitate reclassification action on the remaining pre-amendments Class
III 510(k)s.
Q: Accelerated Approval
Answer:
Allows earlier approval of drugs to treat serious diseases and those that fill an
unmet medical need based on a surrogate endpoint.
Q: Action Letter
Answer:
Official communication from FDA informing an NDA or BLA sponsor of an
agency decision; includes approvable, not approvable and clinical hold.
Q: ADME
Answer:
Absorption, Distribution, Metabolism and Excretion
Q: Adulterated
Answer:
Product containing any filthy, putrid or decomposed substance; or prepared under
unsanitary conditions; or not made according to GMPs; or containing an unsafe
color additive; or does not meet the requirements of an official compendium
(FD&C Act, SEC. 501 [351])
, Q: Advisory Committee
Answer:
Committees and panels used by FDA to obtain independent expert advice on
scientific, technical and policy matters.
Q: ANDA
Answer:
Abbreviated New Drug Application. Used for generic drugs. Found in 21 CFR
314.92 and 505(j) of the FD&C Act. Are not required to include animal safety and
clinical data to demonstrate safety and efficacy, but for oral dosages forms must
scientifically demonstrate that the drug is bioequivalent to the Reference Listed
Drug (RLD). CMC (Chemistry, Manufacturing and Controls) is required.
Q: Annual Report
Answer:
An annual periodic report or progress report that must be submitted to FDA.
Depending on the type of application for which the report is submitted, it may
include new safety, efficacy and labeling information; preclinical and clinical
investigation summaries; CMC updates; nonclinical laboratory studies; and
completed unpublished clinical trials
Q: Approved
Answer:
FDA designation given to drugs, biologics and medical devices that have been
granted marketing approval
Q: Banned Device
Answer:
Device presenting a substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
Q: BIMO
Answer:
Bioresearch Monitoring Program
Q: Bioequivalence
