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 designation provides 6 months of additional market exclusivity in exchange for conducting pediatric studies?

    Answer: Best Pharmaceuticals for Children Act (BPCA) written request fulfillment

    Fulfilling an FDA Written Request under BPCA grants sponsors 6 months of additional market exclusivity (pediatric exclusivity).

  2. In a CTD submission, where is the Drug Substance (API) information primarily located?

    Answer: Module 3.2.S

    Module 3.2.S contains the Drug Substance (API) information including manufacturing, characterization, specifications, and stability data.

  3. What distinguishes a Biologics License Application (BLA) from a New Drug Application (NDA)?

    Answer: BLAs are used for biological products regulated under the Public Health Service Act; NDAs are for drugs under the FD&C Act

    BLAs apply to biological products (e.g., vaccines, monoclonal antibodies) regulated under Section 351 of the Public Health Service Act, while NDAs apply to chemical drugs under the FD&C Act.

  4. What is the primary role of the EU's Committee for Medicinal Products for Human Use (CHMP)?

    Answer: To provide scientific opinions on marketing authorization applications evaluated through the Centralised Procedure

    CHMP issues scientific opinions on marketing authorization applications submitted via the Centralised Procedure, which the European Commission then converts into formal decisions.

  5. A drug receives Breakthrough Therapy Designation (BTD) from the FDA. Which of the following is NOT a benefit of this designation?

    Answer: Automatic approval upon designation

    BTD provides intensive guidance, rolling review, and senior FDA involvement, but does not guarantee or automatically confer approval.

  6. Under 21 CFR Part 601, what is the regulatory pathway for biosimilar products in the US?

    Answer: 351(k) of the Public Health Service Act

    Section 351(k) of the Public Health Service Act, established by the BPCI Act, provides the regulatory pathway for biosimilar and interchangeable biological products.

  7. What is required for an NDA/BLA applicant to use rolling review?

    Answer: The product must have received a qualifying designation such as Fast Track, BTD, or Accelerated Approval

    Rolling review is available to products with Fast Track, Breakthrough Therapy, or similar qualifying designations, allowing FDA to review completed sections as they are submitted.