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US RAC Exam Prep Questions and Answers.
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US RAC Exam PrepQuestions and Answers
Denning [Date] [Course title]
,30-day hold - Correct Answers: (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.")
120-day Safety Report - Correct Answers: Amendment to an NDA containing a safety update due 120
days after the NDA is filed.
180-day Exclusivity - Correct Answers: Protects an ANDA applicant from competition from subsequent
generic versions of the same drug for 180 days.
505(b)(2) Application - Correct Answers: 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)).
Traditional 510(k) - Correct Answers: 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.
Special 510(k) - Correct Answers: For use where device modifications neither affect the intended use nor
alter its fundamental scientific technology. FDA processing time is 30 days.
Abbreviated 510(k) - Correct Answers: 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.
515 Program Initiative - Correct Answers: Created to facilitate reclassification action on the remaining
pre-amendments Class III 510(k)s.
Accelerated Approval - Correct Answers: Allows earlier approval of drugs to treat serious diseases and
those that fill an unmet medical need based on a surrogate endpoint.
, Action Letter - Correct Answers: Official communication from FDA informing an NDA or BLA sponsor of
an agency decision; includes approvable, not approvable and clinical hold.
ADME - Correct Answers: Absorption, Distribution, Metabolism and Excretion
Adulterated - Correct Answers: 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])
Advisory Committee - Correct Answers: Committees and panels used by FDA to obtain independent
expert advice on scientific, technical and policy matters.
ANDA - Correct Answers: 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.
Annual Report - Correct Answers: 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
Approved - Correct Answers: FDA designation given to drugs, biologics and medical devices that have
been granted marketing approval
Banned Device - Correct Answers: Device presenting a substantial deception, unreasonable risk or injury
or illness, or unreasonable direct substantial danger to public health.
BIMO - Correct Answers: Bioresearch Monitoring Program
Bioequivalence - Correct Answers: The absence of a significant difference in the rate and extent to which
the active ingredient or active moiety in pharmaceutical equivalents or pharmaceutical alternatives
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