US RAC Practice Exam Latest Questions With Complete Solutions| Verified Answers

US RAC Practice Exam Latest Questions With Complete Solutions| Verified Answers

[Q]Which meeting is held with the FDA for the purpose of reaching concurrence on the key parameters of the investigational plan for a Class III device?

[A] Agreement meeting

[B] Determination meeting

[C] Presubmission meeting

[D] PMA Day-100 meeting [Ans: - [A] Agreement meeting

[Q]Which meeting held with the FDA is necessary for an otherwise stalled drug product development program to proceed?

[A] Type A

[B] Type B

[C] Type C

[D] Type D [Ans: - [A] Type A

[Q]Which type of meeting is held with the FDA for a Special Protocol Assessment?

[A] Type A

[B] Type B

[C] Type C

[D] Type D [Ans: - [A] Type A

[Q]Within how many days after FDA's receipt of a written request for a meeting should the following meetings occur: Type A, Type B, Type C

[A] 15, 30, 45

[B] 30, 45, 60

[C] 30, 60, 90

[D] 30, 60, 75 [Ans: - [D] 30, 60, 75

[Q]How often does a drug product listing need to occur?

[A] Annually

[B] Every June and December

[C] Quarterly

[D] Once [Ans: - [B] Every June and December

[Q]Upon receipt of a complete PMA, how many days does the FDA have to approve or not approve the PMA?

[A] 90

[B] 120

[C] 150

[D] 180 [Ans: - [D] 180

[Q]What is the one section that is required in an NDA but not in a BLA?

[A] CMC

[B] Clinical data

[C] Field copy certification

[D] Microbiology [Ans: - [C] Field copy certification

[Q]What are the possible outcomes to a PMA?

[A] Approval, unacceptable, refusal

[B] Acceptance, pending, rejected

[C] Approval, Approvable, not approvable, denial

[D] Approval letter, complete response letter, refuse to file letter [Ans: - [C] Approval, Approvable, not approvable, denial

[Q]What are the possible outcomes to an NDA?

[A]Approval, unacceptable, refusal

[B]Approval letter, complete response letter, refuse to file letter

[C]Approval, not approvable, denial

[D]Acceptance, pending, rejected [Ans: - [B]Approval letter, complete response letter, refuse to file letter