US RAC EXAM PREP QUESTIONS AND ANSWERS
(GRADED A)
/. 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.
/.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.
/.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.
/.Class II Device - Answer-Requires general and special controls to ensure safety and
effectiveness. Special controls may include mandatory performance standards, patient
registries for implantable devices and postmarket surveillance. Requires 510(k), unless
exempted; may require clinical trials.
/.Class III Device - Answer-Requires general controls, special controls and premarket
approval (PMA); includes devices that are life-sustaining, life-supporting or pose
significant potential for risk to patient, or are not substantially equivalent to Class I or
Class II devices. PMAs almost always require clinical trials.
/.Clearance - Answer-Devices that receive marketing permission through the 510(k)
process based on demonstrating substantial equivalence to a pre-amendment device or
another device reviewed under section 510(k) of the FD&C Act.
/.Clinical Hold - Answer-FDA order to delay proposed clinical investigation or suspend
an ongoing investigation.
/.Combination Product - Answer-Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
(GRADED A)
/. 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.
/.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.
/.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.
/.Class II Device - Answer-Requires general and special controls to ensure safety and
effectiveness. Special controls may include mandatory performance standards, patient
registries for implantable devices and postmarket surveillance. Requires 510(k), unless
exempted; may require clinical trials.
/.Class III Device - Answer-Requires general controls, special controls and premarket
approval (PMA); includes devices that are life-sustaining, life-supporting or pose
significant potential for risk to patient, or are not substantially equivalent to Class I or
Class II devices. PMAs almost always require clinical trials.
/.Clearance - Answer-Devices that receive marketing permission through the 510(k)
process based on demonstrating substantial equivalence to a pre-amendment device or
another device reviewed under section 510(k) of the FD&C Act.
/.Clinical Hold - Answer-FDA order to delay proposed clinical investigation or suspend
an ongoing investigation.
/.Combination Product - Answer-Defined in 21 CFR 3.2(e) as a combination of two or
more different types of regulated products, i.e.:
