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US RAC Exam Prep Questions with 100% Correct Answers |
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US RAC Exam Prep Questions with 100% Correct Answers |
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US RAC Exam Prep Questions with100% Correct Answers |
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.
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