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US RAC Exam Prep Questions with Answers
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US RAC Exam Prep Questions withAnswers
30-day hold - -(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 - -Amendment to an NDA containing a safety update
due 120 days after the NDA is filed.
-180-day Exclusivity - -Protects an ANDA applicant from competition from
subsequent generic versions of the same drug for 180 days.
-505(b)(2) Application - -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) - -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) - -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) - -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 - -Created to facilitate reclassification action on the
remaining pre-amendments Class III 510(k)s.
-Accelerated Approval - -Allows earlier approval of drugs to treat serious
diseases and those that fill an unmet medical need based on a surrogate
endpoint.
, -Action Letter - -Official communication from FDA informing an NDA or BLA
sponsor of an agency decision; includes approvable, not approvable and
clinical hold.
-ADME - -Absorption, Distribution, Metabolism and Excretion
-Adulterated - -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 - -Committees and panels used by FDA to obtain
independent expert advice on scientific, technical and policy matters.
-ANDA - -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 - -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 - -FDA designation given to drugs, biologics and medical devices
that have been granted marketing approval
-Banned Device - -Device presenting a substantial deception, unreasonable
risk or injury or illness, or unreasonable direct substantial danger to public
health.
-BIMO - -Bioresearch Monitoring Program
-Bioequivalence - -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 - -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 - -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 - -Biologics License Application
-CBE-30 - -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 - -Center for Biologics Evaluation and Research
-CDER - -Center for Drug Evaluation and Research
-CDRH - -Center for Devices and Radiological Health
-Consent Form (CF or ICF) - -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) - -Required by certain countries to
prove that an exported product can be legally marketed in the US.
-CFR - -Code of Federal Regulations
-Class I Device - -Low-risk device requiring general controls to ensure safety
and effectiveness.
-Class II Device - -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 - -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 - -Devices that receive marketing permission through the 510(k)
process based on demonstrating substantial equivalence to a pre-
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