US RAC Exam | Study Guide & Practice Test for Revenue Cycle Auditor Certification
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.")
120-day Safety Report - (answer)Amendment to an NDA containing a safety update due 120 days after
the NDA is filed.
180-day Exclusivity - (answer)Protects an ANDA applicant from competition from subsequent generic
versions of the same drug for 180 days.
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)).
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.
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.
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.
515 Program Initiative - (answer)Created to facilitate reclassification action on the remaining pre-
amendments Class III 510(k)s.
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.
,US RAC Exam | Study Guide & Practice Test for Revenue Cycle Auditor Certification
Action Letter - (answer)Official communication from FDA informing an NDA or BLA sponsor of an agency
decision; includes approvable, not approvable and clinical hold.
ADME - (answer)Absorption, Distribution, Metabolism and Excretion
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])
Advisory Committee - (answer)Committees and panels used by FDA to obtain independent expert advice
on scientific, technical and policy matters.
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.
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
Approved - (answer)FDA designation given to drugs, biologics and medical devices that have been
granted marketing approval
Banned Device - (answer)Device presenting a substantial deception, unreasonable risk or injury or
illness, or unreasonable direct substantial danger to public health.
BIMO - (answer)Bioresearch Monitoring Program
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.
, US RAC Exam | Study Guide & Practice Test for Revenue Cycle Auditor Certification
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.
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.
BLA - (answer)Biologics License Application
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.
CBER - (answer)Center for Biologics Evaluation and Research
CDER - (answer)Center for Drug Evaluation and Research
CDRH - (answer)Center for Devices and Radiological Health
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.
Certificate to Foreign Government (CFG) - (answer)Required by certain countries to prove that an
exported product can be legally marketed in the US.
CFR - (answer)Code of Federal Regulations
Class I Device - (answer)Low-risk device requiring general controls to ensure safety and effectiveness.
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.")
120-day Safety Report - (answer)Amendment to an NDA containing a safety update due 120 days after
the NDA is filed.
180-day Exclusivity - (answer)Protects an ANDA applicant from competition from subsequent generic
versions of the same drug for 180 days.
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)).
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.
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.
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.
515 Program Initiative - (answer)Created to facilitate reclassification action on the remaining pre-
amendments Class III 510(k)s.
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.
,US RAC Exam | Study Guide & Practice Test for Revenue Cycle Auditor Certification
Action Letter - (answer)Official communication from FDA informing an NDA or BLA sponsor of an agency
decision; includes approvable, not approvable and clinical hold.
ADME - (answer)Absorption, Distribution, Metabolism and Excretion
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])
Advisory Committee - (answer)Committees and panels used by FDA to obtain independent expert advice
on scientific, technical and policy matters.
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.
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
Approved - (answer)FDA designation given to drugs, biologics and medical devices that have been
granted marketing approval
Banned Device - (answer)Device presenting a substantial deception, unreasonable risk or injury or
illness, or unreasonable direct substantial danger to public health.
BIMO - (answer)Bioresearch Monitoring Program
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.
, US RAC Exam | Study Guide & Practice Test for Revenue Cycle Auditor Certification
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.
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.
BLA - (answer)Biologics License Application
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.
CBER - (answer)Center for Biologics Evaluation and Research
CDER - (answer)Center for Drug Evaluation and Research
CDRH - (answer)Center for Devices and Radiological Health
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.
Certificate to Foreign Government (CFG) - (answer)Required by certain countries to prove that an
exported product can be legally marketed in the US.
CFR - (answer)Code of Federal Regulations
Class I Device - (answer)Low-risk device requiring general controls to ensure safety and effectiveness.
