RAC US Practice Test

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• 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?
• PDP meeting
• Agreement Meeting
• Pre-IDE meeting
• Type A meeting
• Answer B

• 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 thefollowing is TRUE?
• The sponsor should submit the SPA request within
  30 days following the start of the trial to
  expedite FDA feedback
• An SPA provides an opportunity to focus on
  general drug development issues
• The SPA request will be handled as a request for
  a Type B meeting
• A sponsor can submit a revised protocol while the
  agency is reviewing an earlier version of the
  same protocol
• Answer D

• Devices that are exempt from premarket
  notification are
• All Class I devices
• Some Class I devices
• Most Class I devices and some Class II devices
• All Class I devices and some Class II devices
• Answer C

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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

• The following applies to autologous chondrocytes
  expanded in vitro for the repair of cartilage
  defects
• Regulated under Section 351 of the Public Health
  Service Act and no premarket approval required
• Regulated under Section 351 of the Public Health
  Service Act and premarket approval required
• Regulated under Section 361 of the Public Health
  Service Act and no premarket approval required
• Regulated under Section 361 of the Public Health
  Service Act and premarket approval required
• Answer B

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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• In order to be approved by FDA, a generic drug
  must be therapeutically equivalent to the
  branded product with the exception of
• Dosage Form
• Route of Administration
• Inactive Ingredient(s)
• Labeling
• Answer C

• 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 thestudy design,
  which of the following regulatory strategies has
  to occur prior to initiating the pivotal study?
• Request Fast Track designation
• Request priority review
• Request approval under Subpart H, Accelerated
  Approval of New Drugs for Serious or Life
  Threatening Illness
• Request Special Protocol Assessment
• Answer D

• 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?
• Medicare and Medicaid Patient Protection Act of
  1987
• Food, Drug, and Cosmetic Act of 1938 (FDC Act)
• Food and Drug Administration Modernization Act of
  1997 (FDAMA)
• Food and Drug Administration Amendments Act of
  2007 (FDAAA)
• Answer A

5

• 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
• The request for proprietary name approval may be
  submitted with the NDA.
• The proprietary name submission package may be
  Submitted up to one month after NDA submission.
• The request for proprietary name approval may be
  submitted prior to the NDA.
• 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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