RAC GS Exam

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First you need to know what is RAC GS? 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 related to the international practice of
regulatory affairs, with special attention paid
to global standards from ICH, GHTF (through IMDRF)
Content by Raps.org
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Here we present you RAC GS Real Exam Questions.
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Question No 1
The Food and Drug Administration Modernization
Act (FDAMA) established two types of formal 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
that 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 to 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-hypertensive and anti-diabetic drugs.
However, there is no Reference Listed Drug (RLD)
for the proposed 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 cartilage
defects A. Regulated under Section 351 of the
Public Health Service Act and no premarket
approval required B. Regulated under Section 351
of the Public Health Service Act and premarket
approval required C. Regulated under Section 361
of the Public Health Service Act and no premarket
approval required D. Regulated under Section 361
of the Public Health Service Act and premarket
approval required Answer B
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Question No 6
Which of the following is the best regulatory
pathway for drugs containing similar active
ingredients 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 branded
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 multiforme,
which is the deadliest and most common form of
malignant brain tumor. The compound team has
designed a pivotal study protocol with a
clinically meaningful and well-established
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 programs to
prescribe or recommend that the patient use a
particular manufacturer's medical products 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 (FDC 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 development. The
NDA will be submitted in six months. All of the
following are Relevant to the proprietary 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
submission. 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 proposed
proprietary name submitted with the NDA within 90
days of the receipt of the complete
submission. Answer B
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