Practice Test Geeks(RAC) Regulatory Affairs Certification Practice Test
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Regulatory Frameworks Flashcards

7 cards from real RAC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.

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  1. Under FDA's accelerated approval pathway (21 CFR Part 314 Subpart H), a surrogate endpoint used for approval must be:

    Answer: Reasonably likely to predict clinical benefit

    Accelerated approval may be based on a surrogate endpoint that is 'reasonably likely to predict' clinical benefit, with confirmatory trials required post-approval.

  2. Which ICH guideline provides recommendations on the content and format of Clinical Overview and Clinical Summary documents in the CTD?

    Answer: ICH M4E (CTD for Registration of Pharmaceuticals — Efficacy)

    ICH M4E specifically addresses the efficacy component of the Common Technical Document, including guidance on Clinical Overview and Clinical Summary content.

  3. A regulatory affairs professional must submit a Field Alert Report (FAR) under 21 CFR 314.81. What triggers a FAR submission?

    Answer: Information concerning any incident that causes the drug product to be mistaken for or adulterated, or which may cause death or serious injury

    FARs must be submitted within 3 business days for incidents involving mixups, contamination, significant chemical or physical changes, or labeling errors with potential for harm.

  4. Under the EU Clinical Trials Regulation (CTR 536/2014), the Clinical Trial Information System (CTIS) serves what primary function?

    Answer: It serves as the single EU portal for submitting and assessing clinical trial applications

    CTIS is the single portal that harmonizes clinical trial application submission, assessment coordination, and transparency reporting across EU member states under CTR 536/2014.

  5. Brazil's ANVISA uses which regulatory framework for classifying and approving medical devices?

    Answer: RDC 185/2001 for medical devices (now superseded by RDC 751/2022)

    Brazil's ANVISA updated its medical device regulatory framework; RDC 751/2022 replaced the older RDC 185/2001, establishing new requirements for device registration.

  6. Under 21 CFR Part 58 (Good Laboratory Practice for Nonclinical Laboratory Studies), a Quality Assurance Unit (QAU) inspection of a study must be conducted:

    Answer: At intervals adequate to ensure integrity, including at critical study phases

    GLP requires the QAU to inspect each study at intervals adequate to ensure integrity of the study, with inspections at critical phases of the study being specifically required.

  7. Which provision of the FD&C Act allows FDA to require Risk Evaluation and Mitigation Strategies (REMS) for drugs that pose serious safety risks?

    Answer: Section 505-1, added by FDAAA 2007

    Section 505-1 of the FD&C Act, added by the Food and Drug Administration Amendments Act of 2007 (FDAAA), grants FDA authority to require REMS for drugs with serious risks.