What is RAC?

The Regulatory Affairs Certification (RAC) is

a professional certification. The primary
purpose of a professional certification
program is to provide an independent
assessment of the knowledge, skills and/or
competencies required for competent
performance of a professional role.
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Question No 1:

An orphan drug product means a product intended for use in a rare disease or condition as
defined in FD&C Act Section 526. According to regulations, what constitutes a
rare disease or condition?

A. A disease or condition which affects fewer than 200,000 people in the US

B. A disease or condition which affects fewer than 2% of the population in the US
C. A disease or condition identified as rare by the American Medical Association.
D. A disease or condition for which the mode of action has not been determined.

Answer: A

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Question No 2:

While reviewing product complaint files for MDR reportability, you noticed a complaint re
garding a common failure mode of an implantable screw. There was no patient involveme
nt and no adverse consequences were reported in the complaint. Your firm has initiated a
Class I recall for this implantable screw due to safety issues associated
with this failure mode. As a regulatory professional your decision is:

A. This complaint is reportable an MDR will be filed with FDA within 30 days
B. A review of the complaint history is needed to see whether such failure mode will likely
cause or contribute to death or serious injury
C. No MDR is needed as there is no patient involvement and no adverse consequences
were reported
D. No MDR is needed but you will file this complaint in the recall file

Answer: A
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Question No 3:

In the original application for drug "X," your company submitted a comparability protocol outlining a series of propo
sed, repetitive container closure system changes, the tests and studies that would be used to evaluate the changes,
and the acceptance criteria that would be met. The application has since been approveSubsequently, the
comparability test results did not meet some of the predefined acceptance criteriWhat regulatory option does your
company have in this situation?

A. Your company may implement the change(s), but an explanation as to why some of the acceptance criteria were
not met must be included within the next Annual Report
B. Your company may still pursue the change(s) and should submit a Prior Approval Supplement that provides the su
pporting data to justify why the change will not adversely affect the identity, strength, quality, purity and potency
of the specific drug product as these factors relate to the product's safety and effectiveness
C. Your company may still pursue the change(s) and should submit a CBE-30 that provides the supporting data to jus
tify why the change will not adversely affect the identity, strength, quality, purity and potency of the specific drug
product as these factors relate to the product's safety and effectiveness
D. There is no further regulatory option the proposed change(s) cannot be implemented since the predefined accep
tance criteria were not met.

Answer: B
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Question No 4:

The following biological products are regulated by CBER EXCEPT:

A. Immunizing toxoids
B. Monoclonal antibodies for in vitro use
C. Monoclonal antibodies for in vivo use
D. Infusion of animal sourced cells into a human

Answer: A

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Question No 5:

A medical device may be exported under Section 801(e) of the FD&C Act and shall not be d
eemed to be adulterated or misbranded under the act if all of the following apply
for the device EXCEPT:

A. It is in accordance with the specifications of the foreign purchaser

B. It is not in conflict with the laws of the country to which it is intended for export
C. It is 510(k) cleared or PMA approved
D. It is labeled on the outside of the shipping package that it is "intended for export only"

Answer: C

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Question No 6:

The Food and Drug Administration Amendments Act of 2007 (FDAAA) established all of th
e following EXCEPT:

A. Expanded FDA authority for postmarket safety of drugs.

B. Reauthorization of prescription drug and medical device user fees.
C. Incentives to medical device manufacturers to create devices for children.
D. Voluntary registration of clinical trials in FDA database.

Answer: D

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Question No 7:

Senior management at your company asked you to develop a justification for Fast Track sta
tus for an investigational new cancer drug. Which of the following would NOT be
an appropriate justification for FDA granting Fast Track status for this investigational new d
rug?

A. Preliminary evidence indicates the new drug may decrease clinically significant toxicity o
f available treatment
B. Cancer is considered by FDA to be a serious disease
C. Preliminary evidence indicates the new drug has potential for superior effectiveness co
mpared to available treatment
D. Documentation can be provided that the cancer drug meets safety and effectiveness sta
ndards required for Fast Track status

Answer: D
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Question No 8:

A company is evaluating next steps for a small Phase 1/2 clinical trial. There are four cohorts and the compa
ny has just completed enrollment of the third cohort. Efficacy
data from immunology testing have revealed a small signal was detecte Based on these data the company b
elieves the fourth cohort should be dosed with a higher
concentration of drug product. The concentration required is higher than the current dose of the drug produ
ct and may not be supported nonclinical toxicology studies. The higher dose also will require some additiona
l product development and the time to manufacture is estimated to be approximately 18 months. What is th
e best regulatory
approach?

A. Recruitment on the current clinical protocol should be put on hold for two years to wait for the new drug
product.
B. The current clinical protocol should be terminated and a new clinical protocol written with the new dosing
supported by nonclinical studies.
C. The clinical protocol should be amended and increased dosing schedule be incorporated into the protocol.
D. The clinical protocol should be amended and the dosing of the current drug product increased.

Answer: B https://www.certs4you.com/raps/rac-us-dumps.html
Question No 9:

A sponsor wishes to obtain permission from FDA to submit an ANDA for a drug product th
at varies from the Reference Listed Drug (RLD) in route of administration, dosage form or s
trength, but anticipates the labeling will be identical to that of the RLWhat process should
be used to apply for that permission from FDA?

A. Citizen Petition
B. Pre-NDA Meeting
C. Suitability Petition
D. Notice of Opportunity for Hearing

Answer: C

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Question No 10:

Company X is planning to conduct a bioequivalence (BE) study for its proposed generic dru
g product. The clinical protocol requires a multiple-dose study where the total
daily dose exceeds that specified in the labeling of the reference approved drug product. A
s a regulatory professional, which choice below is the correct action concerning this bioeq
uivalence study?

A. The bioequivalence study may be started without further FDA action since the drug prod
uct is already the subject of an approved NDA
B. An Investigational New Drug Application (IND) must be filed prior to initiating the BE
Study
C. Request a Type B meeting with FDA for protocol review and approval
D. Submit a suitability petition requesting the use of the increased dosage range

Answer: B
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