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RAC-GS - Regulatory Affairs Certification (RAC)

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Sample Questions

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

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

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

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

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

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

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

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

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 (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

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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