US RAC EXAM 2026 TEST BANK
COMPLETE REVIEW SOLUTIONS
FRAMEWORK
◉ 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
COMPLETE REVIEW SOLUTIONS
FRAMEWORK
◉ 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
