Practice Test Geeks(CRAP) Certified Regulatory Affairs Professional Practice Test
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Regulatory Strategy & Submission Management Flashcards

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

Read the first 7 Regulatory Strategy & Submission Management flashcards as text

  1. Under FDA regulations, which type of IND allows a marketed drug to be studied for a new indication without triggering full IND requirements for the initial phase?

    Answer: Exploratory IND (Phase 0 IND)

    An Exploratory IND (Phase 0) supports limited early human studies with subtherapeutic doses aimed at gaining pharmacokinetic or mechanistic data.

  2. When preparing a regulatory gap analysis for a product entering a new market, what is the FIRST step?

    Answer: Identify the applicable regulatory requirements and compare them to the existing data package

    A gap analysis begins by mapping existing data against target market requirements to identify missing studies, formats, or documentation.

  3. What is the maximum review period for a Standard Review NDA under PDUFA VII goals?

    Answer: 10 months

    Under PDUFA VII, standard review NDAs have a 10-month review goal from the date of filing (60 days post-submission).

  4. A regulatory affairs team must decide whether to submit a Prior Approval Supplement (PAS) or a Changes Being Effected (CBE-30) supplement for a manufacturing change. Which factor determines this?

    Answer: The potential risk of the change to product quality, safety, or efficacy

    The regulatory reporting category (PAS, CBE-30, CBE-0, or Annual Report) is determined by the risk level the change poses to product quality and patient safety.

  5. Which regulatory tool allows FDA to approve a drug based on a surrogate endpoint reasonably likely to predict clinical benefit, with post-marketing confirmation required?

    Answer: Accelerated Approval

    Accelerated Approval (21 CFR Part 314 Subpart H) permits use of surrogate or intermediate endpoints with mandatory confirmatory post-marketing trials.

  6. In the ICH CTD structure, where is the Drug Substance section located?

    Answer: Module 3.2.S

    Module 3.2.S contains the Drug Substance (active pharmaceutical ingredient) chemistry, manufacturing, and controls information in the CTD.

  7. A company receives an FDA Complete Response Letter (CRL). Within what timeframe must the company resubmit to be considered a Class 1 resubmission?

    Answer: Within 3 months

    A Class 1 resubmission addresses minor deficiencies and must be filed within 3 months of the CRL to qualify for a 2-month review goal.