Exam (elaborations)

US RAC Exam Prep UPDATED Exam Questions and CORRECT Answers

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Contains Questions & answers

Institution US RAC
Course US RAC

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US RAC Exam Prep UPDATED Exam
Questions and CORRECT Answers

30-day hold - Correct Answer- (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 - Correct Answer- Amendment to an NDA containing a safety update
due 120 days after the NDA is filed.

180-day Exclusivity - Correct Answer- Protects an ANDA applicant from competition from
subsequent generic versions of the same drug for 180 days.

505(b)(2) Application - Correct 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) - Correct 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) - Correct 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) - Correct 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 - Correct Answer- Created to facilitate reclassification action on the
remaining pre-amendments Class III 510(k)s.

,Accelerated Approval - Correct 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 - Correct Answer- Official communication from FDA informing an NDA or
BLA sponsor of an agency decision; includes approvable, not approvable and clinical hold.

ADME - Correct Answer- Absorption, Distribution, Metabolism and Excretion

Adulterated - Correct 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 - Correct Answer- Committees and panels used by FDA to obtain
independent expert advice on scientific, technical and policy matters.

ANDA - Correct 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 - Correct 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 - Correct Answer- FDA designation given to drugs, biologics and medical devices
that have been granted marketing approval

Banned Device - Correct Answer- Device presenting a substantial deception, unreasonable
risk or injury or illness, or unreasonable direct substantial danger to public health.

BIMO - Correct Answer- Bioresearch Monitoring Program

, Bioequivalence - Correct Answer- 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 - Correct Answer- 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 - Correct Answer- 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 - Correct Answer- Biologics License Application

CBE-30 - Correct Answer- 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 - Correct Answer- Center for Biologics Evaluation and Research

CDER - Correct Answer- Center for Drug Evaluation and Research

CDRH - Correct Answer- Center for Devices and Radiological Health

Consent Form (CF or ICF) - Correct Answer- 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) - Correct Answer- Required by certain countries to
prove that an exported product can be legally marketed in the US.

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