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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 ex
pedite 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 th
e 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-hypertensi

ve and anti-diabetic drugs. However, there is no Reference Listed Drug (RLD) for the proposed co
mbination. 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 de
fects:

A. Regulated under Section 351 of the Public Health Service Act and no premarket approval requ
ired
B. Regulated under Section 351 of the Public Health Service Act and premarket approval require
d
C. Regulated under Section 361 of the Public Health Service Act and no premarket approval requ
ired
D. Regulated under Section 361 of the Public Health Service Act and premarket approval require
d

Answer: B https://www.exactcert.com/RAC-US-exam-questions.html
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