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US RAC Exam Prep 2024 with correct answers
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US RAC Exam Prep 2024 with correct answers
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US RAC Exam Prep 2024 with correct answers30-day hold - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔Amendment to an NDA containing a safety
update due xx days after the NDA is filed.
180-day Exclusivity - ** VERIFIED ANSWERS **✔✔Protects an ANDA applicant from competition
from subsequent generic versions of the same drug for how many days?
505(b)(2) Application - ** VERIFIED ANSWERS **✔✔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) - ** VERIFIED 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) - ** VERIFIED 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) - ** VERIFIED 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 - ** VERIFIED ANSWERS **✔✔Created to facilitate reclassification action on
the remaining pre-amendments Class III 510(k)s.
Accelerated Approval - ** VERIFIED 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 - ** VERIFIED ANSWERS **✔✔Official communication from FDA informing an NDA
or BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold.
ADME - ** VERIFIED ANSWERS **✔✔Absorption, Distribution, Metabolism and Excretion
Adulterated - ** VERIFIED 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 - ** VERIFIED ANSWERS **✔✔Committees and panels used by FDA to obtain
independent expert advice on scientific, technical and policy matters.
ANDA - ** VERIFIED ANSWERS **✔✔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.
Annual Report - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔FDA designation given to drugs, biologics and medical
devices that have been granted marketing approval
, Banned Device - ** VERIFIED ANSWERS **✔✔Device presenting a substantial deception,
unreasonable risk or injury or illness, or unreasonable direct substantial danger to public health.
BIMO - ** VERIFIED ANSWERS **✔✔Bioresearch Monitoring Program
Bioequivalence - ** VERIFIED 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 when administered at the
same molar dose under similar conditions in an appropriately designed study.
Biologic - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔Biologics License Application
CBE-30 - ** VERIFIED ANSWERS **✔✔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 - ** VERIFIED ANSWERS **✔✔Center for Biologics Evaluation and Research
CDER - ** VERIFIED ANSWERS **✔✔Center for Drug Evaluation and Research
CDRH - ** VERIFIED ANSWERS **✔✔Center for Devices and Radiological Health
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