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First you need to know what is Rac US

? And how much this
certification beneficent for you?

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Regulatory Affairs Certification (RAC) US Exam

Regulatory Affairs Certification (RAC) An individual certification for our
global industry. ... RAC (Global): Knowledge and critical thinking skills r
elated to the international practice of regulatory affairs, with special a
ttention paid to global standards from ICH, GHTF (through IMDRF)
Content by Raps.org

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https://www.exams4sure.net/aRac US/Rac US-exam-questions-dumps.html

Question No 1:
The Food and Drug Administration Modernization Act (FDAMA) established two types of for
mal early collaboration meetings. Which of the following is one of those meetings?
A. PDP meeting
B. Agreement Meeting
C. Pre-IDE meeting
D. Type A meeting
Answer: B

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Question No 2:
A sponsor intends to submit a Special Protocol Assessment (SPA) request for a clinical trial t
hat will form the primary basis of an efficacy claim in an NDA. Which of the
following is TRUE?
A. The sponsor should submit the SPA request within 30 days following the start of the trial t
o expedite FDA feedback
B. An SPA provides an opportunity to focus on general drug development issues
C. The SPA request will be handled as a request for a Type B meeting
D. A sponsor can submit a revised protocol while the agency is reviewing an earlier version of
the same protocol
Answer: D
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Question No 3:
Devices that are exempt from premarket notification are:

A. All Class I devices

B. Some Class I devices
C. Most Class I devices and some Class II devices
D. All Class I devices and some Class II devices
Answer: C

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Question No 4:
Your company wishes to seek approval of a combination of individually approved anti-hype
rtensive and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the p
roposed combination. Which of the following regulatory pathways is most applicable?
A. 505(b)(2)
B. 510(k)
C. 505(b)(1)
D. 505(j)
Answer: A

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Question No 5:
The following applies to autologous chondrocytes expanded in vitro for the repair of cartila
ge defects:
A. Regulated under Section 351 of the Public Health Service Act and no premarket approval r
equired
B. Regulated under Section 351 of the Public Health Service Act and premarket approval requ
ired
C. Regulated under Section 361 of the Public Health Service Act and no premarket approval r
equired
D. Regulated under Section 361 of the Public Health Service Act and premarket approval requ
ired
Answer: B
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Question No 6:
Which of the following is the best regulatory pathway for drugs containing similar active ing
redients as a previously approved drug for a new indication?
A. 505(j) ANDA
B. 505(b)(1) NDA
C. 505(b)(2) NDA
D. 505 (d) Substantial Evidence of Effectiveness
Answer: C

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Question No 7:
In order to be approved by FDA, a generic drug must be therapeutically equivalent to the br
anded product with the exception of:
A. Dosage Form
B. Route of Administration
C. Inactive Ingredient(s)
D. Labeling
Answer: C

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Question No 8:
Your company is developing a New Chemical Entity (NCE) drug to treat Glioblastoma multif
orme, which is the deadliest and most common form of malignant brain tumor. The compo
und team has designed a pivotal study protocol with a clinically meaningful and well-establi
shed primary endpoint. To increase the likelihood FDA will agree with the
study design, which of the following regulatory strategies has to occur prior to initiating the
pivotal study?
A. Request Fast Track designation
B. Request priority review
C. Request approval under Subpart H, Accelerated Approval of New Drugs for Serious or Life
Threatening Illness
D. Request Special Protocol Assessment
Answer: D

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Question No 9:
Which federal law made it illegal for physicians being reimbursed by federally funded progr
ams to prescribe or recommend that the patient use a particular manufacturer's medical pr
oducts when the doctor receives payment from that manufacturer?
A. Medicare and Medicaid Patient Protection Act of 1987
B. Food, Drug, and Cosmetic Act of 1938 (FD&C Act)
C. Food and Drug Administration Modernization Act of 1997 (FDAMA)
D. Food and Drug Administration Amendments Act of 2007 (FDAAA)
Answer: A

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Question No 10:
Company Z selected a proprietary name for its new molecular entity, currently in developm
ent. The NDA will be submitted in six months. All of the following are Relevant to the propri
etary name EXCEPT:
A. The request for proprietary name approval may be submitted with the NDA.
B. The proprietary name submission package may be Submitted up to one month after NDA s
ubmission.
C. The request for proprietary name approval may be submitted prior to the NDA.
D. FDA will communicate to the applicant a tentative acceptance or non-acceptance of the pr
oposed proprietary name submitted with the NDA within 90 days of the receipt of the compl
ete submission.
Answer: B
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