US RAC EXAM PREP 2024
US RAC EXAM PREP 2024 WITH GUARANTEED ACCURATE ANSWERS
30-day hold - ACCURATE ANSWERS✔✔ (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 - ACCURATE ANSWERS✔✔ Amendment to an
NDA containing a safety update due 120 days after the NDA is filed.
180-day Exclusivity - ACCURATE ANSWERS✔✔ Protects an ANDA
applicant from competition from subsequent generic versions of the
same drug for 180 days.
,505(b)(2) Application - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ Created to
facilitate reclassification action on the remaining pre-amendments Class
III 510(k)s.
,Accelerated Approval - ACCURATE ANSWERS✔✔ Allows earlier
approval of drugs to treat serious diseases and those that fill an unmet
medical need based on a surrogate endpoint.
Action Letter - ACCURATE ANSWERS✔✔ Official communication
from FDA informing an NDA or BLA sponsor of an agency decision;
includes approvable, not approvable and clinical hold.
ADME - ACCURATE ANSWERS✔✔ Absorption, Distribution,
Metabolism and Excretion
Adulterated - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ Committees and
panels used by FDA to obtain independent expert advice on scientific,
technical and policy matters.
ANDA - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ FDA designation given to
drugs, biologics and medical devices that have been granted marketing
approval
Banned Device - ACCURATE ANSWERS✔✔ Device presenting a
substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
BIMO - ACCURATE ANSWERS✔✔ Bioresearch Monitoring Program
Bioequivalence - ACCURATE ANSWERS✔✔ 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
US RAC EXAM PREP 2024 WITH GUARANTEED ACCURATE ANSWERS
30-day hold - ACCURATE ANSWERS✔✔ (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 - ACCURATE ANSWERS✔✔ Amendment to an
NDA containing a safety update due 120 days after the NDA is filed.
180-day Exclusivity - ACCURATE ANSWERS✔✔ Protects an ANDA
applicant from competition from subsequent generic versions of the
same drug for 180 days.
,505(b)(2) Application - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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) - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ Created to
facilitate reclassification action on the remaining pre-amendments Class
III 510(k)s.
,Accelerated Approval - ACCURATE ANSWERS✔✔ Allows earlier
approval of drugs to treat serious diseases and those that fill an unmet
medical need based on a surrogate endpoint.
Action Letter - ACCURATE ANSWERS✔✔ Official communication
from FDA informing an NDA or BLA sponsor of an agency decision;
includes approvable, not approvable and clinical hold.
ADME - ACCURATE ANSWERS✔✔ Absorption, Distribution,
Metabolism and Excretion
Adulterated - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ Committees and
panels used by FDA to obtain independent expert advice on scientific,
technical and policy matters.
ANDA - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ 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 - ACCURATE ANSWERS✔✔ FDA designation given to
drugs, biologics and medical devices that have been granted marketing
approval
Banned Device - ACCURATE ANSWERS✔✔ Device presenting a
substantial deception, unreasonable risk or injury or illness, or
unreasonable direct substantial danger to public health.
BIMO - ACCURATE ANSWERS✔✔ Bioresearch Monitoring Program
Bioequivalence - ACCURATE ANSWERS✔✔ 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
