US RAC EXAM PREP QUESTIONS AND
ANSWERS GRADED A+ 2026
30-day hold - ANS 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 - ANS Amendment to an NDA containing a safety update due xx days
after the NDA is filed.
180-day Exclusivity - ANS Protects an ANDA applicant from competition from subsequent
generic versions of the same drug for how many days?
505(b)(2) Application - ANS An application submitted under what section 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) - ANS 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.
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
1
,Special 510(k) - ANS 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) - ANS 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 - ANS Created to facilitate reclassification action on the remaining pre-
amendments Class III 510(k)s.
Accelerated Approval - ANS Allows earlier approval of drugs to treat serious diseases and
those that fill an unmet medical need based on a surrogate endpoint.
Action Letter - ANS Official communication from FDA informing an NDA or BLA sponsor of an
agency decision; includes approvable, not approvable and clinical hold.
ADME - ANS Absorption, Distribution, Metabolism and Excretion
Adulterated - ANS 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 - ANS Committees and panels used by FDA to obtain independent expert
advice on scientific, technical and policy matters.
ANDA - ANS Type of 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.
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
2
, Annual Report - ANS A type of report that must be submitted to FDA regularly. 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 - ANS FDA designation given to drugs, biologics and medical devices that have
been granted marketing approval
Banned Device - ANS Device presenting a substantial deception, unreasonable risk or injury
or illness, or unreasonable direct substantial danger to public health.
BIMO - ANS Bioresearch Monitoring Program
Bioequivalence - ANS 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.
Biologic - ANS 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 - ANS 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 - ANS Biologics License Application
CBE-30 - ANS 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
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
3
ANSWERS GRADED A+ 2026
30-day hold - ANS 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 - ANS Amendment to an NDA containing a safety update due xx days
after the NDA is filed.
180-day Exclusivity - ANS Protects an ANDA applicant from competition from subsequent
generic versions of the same drug for how many days?
505(b)(2) Application - ANS An application submitted under what section 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) - ANS 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.
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
1
,Special 510(k) - ANS 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) - ANS 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 - ANS Created to facilitate reclassification action on the remaining pre-
amendments Class III 510(k)s.
Accelerated Approval - ANS Allows earlier approval of drugs to treat serious diseases and
those that fill an unmet medical need based on a surrogate endpoint.
Action Letter - ANS Official communication from FDA informing an NDA or BLA sponsor of an
agency decision; includes approvable, not approvable and clinical hold.
ADME - ANS Absorption, Distribution, Metabolism and Excretion
Adulterated - ANS 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 - ANS Committees and panels used by FDA to obtain independent expert
advice on scientific, technical and policy matters.
ANDA - ANS Type of 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.
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
2
, Annual Report - ANS A type of report that must be submitted to FDA regularly. 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 - ANS FDA designation given to drugs, biologics and medical devices that have
been granted marketing approval
Banned Device - ANS Device presenting a substantial deception, unreasonable risk or injury
or illness, or unreasonable direct substantial danger to public health.
BIMO - ANS Bioresearch Monitoring Program
Bioequivalence - ANS 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.
Biologic - ANS 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 - ANS 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 - ANS Biologics License Application
CBE-30 - ANS 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
@COPYRIGHT 2026/2027 ALL RIGHTS RESERVED
3
