US RAC Exam Prep latest 2023-2024 /174 Questions
With Complete Solutions Graded (A+)
Quiz :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.")
Quiz :120-day Safety Report - √Answer :Amendment to an NDA containing a
safety update due 120 days after the NDA is filed.
Quiz :180-day Exclusivity - √Answer :Protects an ANDA applicant from
competition from subsequent generic versions of the same drug for 180 days.
Quiz :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)).
Quiz :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.
Quiz :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.
Quiz :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.
Quiz :515 Program Initiative - √Answer :Created to facilitate reclassification
action on the remaining pre-amendments Class III 510(k)s.
,Quiz :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.
Quiz :Action Letter - √Answer :Official communication from FDA informing an
NDA or BLA sponsor of an agency decision; includes approvable, not
approvable and clinical hold.
Quiz :ADME - √Answer :Absorption, Distribution, Metabolism and Excretion
Quiz :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])
Quiz :Advisory Committee - √Answer :Committees and panels used by FDA to
obtain independent expert advice on scientific, technical and policy matters.
Quiz :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.
Quiz :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
Quiz :Approved - √Answer :FDA designation given to drugs, biologics and
medical devices that have been granted marketing approval
Quiz :Banned Device - √Answer :Device presenting a substantial deception,
unreasonable risk or injury or illness, or unreasonable direct substantial danger
to public health.
Quiz :BIMO - √Answer :Bioresearch Monitoring Program
, Quiz :Bioequivalence - √Answer :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 becomes available
at the site of drug action when administered at the same molar dose under
similar conditions in an appropriately designed study.
Quiz :Biologic - √Answer :A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, protein (except any
chemically synthesized polypeptide), or analogous product, or arsphenamine
or derivative of arsphenamine (or any other trivalent organic arsenic
compound) applicable to the prevention, treatment or cure of disease or
condition of human beings.
Quiz :Biosimilar - √Answer :Under the BPCI Act (Biologics Price Competition
and Innovation Act of 2009), a biological product may be demonstrated to be
"biosimilar" if data show that, among other things, the product is "highly
similar" to an already approved biological product.
Quiz :BLA - √Answer :Biologics License Application
Quiz :CBE-30 - √Answer :Changes Being Effected in 30 days. A submission to an
approved application reporting changes the FDA has identified as having
moderate potential to adversely affect drug product identity, strength, quality,
purity and potency. The supplement must be received by FDA at least 30 days
before product distribution.
Quiz :CBER - √Answer :Center for Biologics Evaluation and Research
Quiz :CDER - √Answer :Center for Drug Evaluation and Research
Quiz :CDRH - √Answer :Center for Devices and Radiological Health
Quiz :Consent Form (CF or ICF) - √Answer :Document used to inform a
potential subject of the risks and benefits of a clinical trial per the Declaration
of Helsinki.
Quiz :Certificate to Foreign Government (CFG) - √Answer :Required by certain
countries to prove that an exported product can be legally marketed in the US.
Quiz :CFR - √Answer :Code of Federal Regulations
With Complete Solutions Graded (A+)
Quiz :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.")
Quiz :120-day Safety Report - √Answer :Amendment to an NDA containing a
safety update due 120 days after the NDA is filed.
Quiz :180-day Exclusivity - √Answer :Protects an ANDA applicant from
competition from subsequent generic versions of the same drug for 180 days.
Quiz :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)).
Quiz :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.
Quiz :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.
Quiz :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.
Quiz :515 Program Initiative - √Answer :Created to facilitate reclassification
action on the remaining pre-amendments Class III 510(k)s.
,Quiz :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.
Quiz :Action Letter - √Answer :Official communication from FDA informing an
NDA or BLA sponsor of an agency decision; includes approvable, not
approvable and clinical hold.
Quiz :ADME - √Answer :Absorption, Distribution, Metabolism and Excretion
Quiz :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])
Quiz :Advisory Committee - √Answer :Committees and panels used by FDA to
obtain independent expert advice on scientific, technical and policy matters.
Quiz :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.
Quiz :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
Quiz :Approved - √Answer :FDA designation given to drugs, biologics and
medical devices that have been granted marketing approval
Quiz :Banned Device - √Answer :Device presenting a substantial deception,
unreasonable risk or injury or illness, or unreasonable direct substantial danger
to public health.
Quiz :BIMO - √Answer :Bioresearch Monitoring Program
, Quiz :Bioequivalence - √Answer :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 becomes available
at the site of drug action when administered at the same molar dose under
similar conditions in an appropriately designed study.
Quiz :Biologic - √Answer :A virus, therapeutic serum, toxin, antitoxin, vaccine,
blood, blood component or derivative, allergenic product, protein (except any
chemically synthesized polypeptide), or analogous product, or arsphenamine
or derivative of arsphenamine (or any other trivalent organic arsenic
compound) applicable to the prevention, treatment or cure of disease or
condition of human beings.
Quiz :Biosimilar - √Answer :Under the BPCI Act (Biologics Price Competition
and Innovation Act of 2009), a biological product may be demonstrated to be
"biosimilar" if data show that, among other things, the product is "highly
similar" to an already approved biological product.
Quiz :BLA - √Answer :Biologics License Application
Quiz :CBE-30 - √Answer :Changes Being Effected in 30 days. A submission to an
approved application reporting changes the FDA has identified as having
moderate potential to adversely affect drug product identity, strength, quality,
purity and potency. The supplement must be received by FDA at least 30 days
before product distribution.
Quiz :CBER - √Answer :Center for Biologics Evaluation and Research
Quiz :CDER - √Answer :Center for Drug Evaluation and Research
Quiz :CDRH - √Answer :Center for Devices and Radiological Health
Quiz :Consent Form (CF or ICF) - √Answer :Document used to inform a
potential subject of the risks and benefits of a clinical trial per the Declaration
of Helsinki.
Quiz :Certificate to Foreign Government (CFG) - √Answer :Required by certain
countries to prove that an exported product can be legally marketed in the US.
Quiz :CFR - √Answer :Code of Federal Regulations
