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Free RAC Practice Questions

10 free, exam-style RAC-Drugs (RAC) practice questions with answers and explanations. No signup required. Work through them below, then take the full free RAC practice test to study every exam domain.

Question 1

A drug substance's chemistry, manufacturing, and controls (CMC) data are being compiled for a marketing application using the ICH Common Technical Document. In which module should this quality information be placed?

  1. Module 3
  2. Module 2
  3. Module 4
  4. Module 5
Show answer & explanation

Correct answer: A - Module 3

Question 2

A company has reformulated an approved small-molecule drug into a new extended-release product. It intends to rely partly on the FDA's previous findings of safety and effectiveness for the original drug and partly on its own bridging studies. Which US application pathway is MOST appropriate?

  1. ANDA, because the active ingredient is already approved
  2. NDA under 505(b)(1)
  3. NDA under 505(b)(2)
  4. BLA under 351(k)
Show answer & explanation

Correct answer: C - NDA under 505(b)(2)

Question 3

An investigational therapy treats a serious condition. Preliminary clinical evidence suggests it may offer substantial improvement over available therapy on a clinically significant endpoint. The sponsor wants the designation that provides intensive FDA guidance and an organizational commitment to expedite development. Which is MOST appropriate to request?

  1. Fast Track designation
  2. Breakthrough Therapy designation
  3. Accelerated Approval
  4. Priority Review
Show answer & explanation

Correct answer: B - Breakthrough Therapy designation

Question 4

A drug in development requires a specific laboratory test to identify the patients for whom it is intended. Beyond the drug application itself, which additional regulatory framework MOST directly applies to this required test?

  1. The in vitro diagnostic (device) framework
  2. Only the drug NDA framework applies
  3. The dietary supplement framework
  4. The veterinary medicinal product framework
Show answer & explanation

Correct answer: A - The in vitro diagnostic (device) framework

Question 5

An unexpected adverse event that is fatal and is reasonably attributed to the investigational drug occurs in a US IND study. Within what timeframe must the sponsor submit the initial IND safety report to FDA?

  1. No later than 15 calendar days
  2. No later than 30 calendar days
  3. Within 24 hours by telephone only
  4. No later than 7 calendar days
Show answer & explanation

Correct answer: D - No later than 7 calendar days

Question 6

A newly identified safety signal warrants adding a warning to an approved US product's labeling, and the sponsor wants to strengthen the safety information as quickly as is permissible. Which submission mechanism BEST balances rapid implementation with compliance?

  1. Defer the change to the next Annual Report
  2. Submit a Prior Approval Supplement and wait for FDA approval before implementing
  3. Submit a Changes Being Effected-0 (CBE-0) supplement
  4. Implement the change immediately with no submission
Show answer & explanation

Correct answer: C - Submit a Changes Being Effected-0 (CBE-0) supplement

Question 7

As a condition of approval, a sponsor agrees in writing to conduct a post-approval pediatric study, but the study is NOT required under any statute or regulation. How is this obligation correctly classified?

  1. Post-Marketing Requirement (PMR)
  2. Post-Marketing Commitment (PMC)
  3. Risk Evaluation and Mitigation Strategy (REMS)
  4. Post-Authorisation Safety Study (PASS)
Show answer & explanation

Correct answer: B - Post-Marketing Commitment (PMC)

Question 8

A sponsor's development program is stalled because FDA has placed the study on clinical hold, and the sponsor needs to meet with the agency as soon as possible to resolve it. Which FDA meeting type is intended for this situation?

  1. Type A
  2. Type B
  3. Type C
  4. Type D
Show answer & explanation

Correct answer: A - Type A

Question 9

At the close of a facility inspection, an FDA investigator issues a Form 483. What does this document represent?

  1. A final agency determination that violations have occurred
  2. A list of the investigator's inspectional observations
  3. A warning letter requiring a response within 15 days
  4. Formal approval of the facility's compliance status
Show answer & explanation

Correct answer: B - A list of the investigator's inspectional observations

Question 10

A sponsor outsources analytical testing of its drug product to a contract laboratory. Which statement BEST reflects the sponsor's responsibility for that outsourced activity?

  1. GxP responsibility passes entirely to the contract laboratory
  2. A purchase order alone adequately governs the relationship
  3. Oversight is needed only if the laboratory is located abroad
  4. The sponsor remains responsible and defines duties in a quality agreement
Show answer & explanation

Correct answer: D - The sponsor remains responsible and defines duties in a quality agreement

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