Practice Test Geeks(RAC) Regulatory Affairs Certification Practice Test
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Regulatory Submissions and Approval 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. Which FDA submission type is used to request approval for a generic drug product?

    Answer: ANDA

    An Abbreviated New Drug Application (ANDA) is the pathway for generic drug approval, referencing a previously approved Reference Listed Drug.

  2. What is the primary purpose of a Pre-Submission (Q-Sub) meeting with the FDA?

    Answer: To seek FDA feedback on planned submissions before they are filed

    A Pre-Submission (Q-Sub) allows sponsors to obtain non-binding FDA feedback on regulatory strategies, study designs, or submission content before filing.

  3. Under 21 CFR Part 314, what is the standard FDA review clock for a standard NDA?

    Answer: 10 months

    FDA's standard review goal for a standard NDA is 10 months from the date of filing.

  4. Which section of a Common Technical Document (CTD) contains the clinical study reports?

    Answer: Module 5

    Module 5 of the CTD contains clinical study reports, including results of clinical pharmacology, efficacy, and safety studies.

  5. A sponsor submits a Type II variation to the EMA. What does this typically involve?

    Answer: A major change that may significantly affect the benefit-risk profile

    A Type II variation involves a major change to a Marketing Authorization that may have a significant impact on the quality, safety, or efficacy of the product.

  6. Which of the following best describes a Complete Response Letter (CRL) from the FDA?

    Answer: A letter notifying the applicant of deficiencies that must be addressed before approval

    A CRL informs the sponsor that FDA cannot approve the application in its current form and lists the deficiencies that must be resolved.

  7. In the EU, what is the Centralised Procedure (CP) most appropriate for?

    Answer: Products containing new active substances or designated orphan medicines

    The Centralised Procedure is mandatory for certain product categories including new active substances, biotechnology products, and orphan medicines, granting a single EU-wide marketing authorization.