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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.

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  1. A company wants to market a drug in the EU and US simultaneously. Which regulatory strategy best supports parallel submissions?

    Answer: Use ICH CTD format for both agencies and align clinical data packages

    The ICH Common Technical Document (CTD) format is accepted by both FDA and EMA, enabling parallel submissions with a harmonized data package.

  2. Which FDA submission pathway is most appropriate for a drug with a condition of use in a small, well-defined rare disease population?

    Answer: Orphan Drug designation with NDA or BLA

    Orphan Drug designation is designed for conditions affecting fewer than 200,000 people in the US, providing incentives including market exclusivity.

  3. A regulatory submission has been placed on clinical hold by the FDA. What is the sponsor's primary next step?

    Answer: Respond in writing to address all FDA concerns within the specified timeframe

    The sponsor must submit a complete response addressing all clinical hold issues raised by FDA before clinical trials can resume.

  4. What is the primary purpose of a Pre-Submission (Q-Sub) meeting with FDA for a medical device?

    Answer: To obtain FDA feedback on testing, study design, or submission requirements prior to formal filing

    Pre-Submission meetings allow device sponsors to get FDA feedback on regulatory strategy, study design, and data requirements before filing.

  5. A company is developing a product that combines a drug with a diagnostic device. Under US regulations, how should the regulatory strategy be approached?

    Answer: Develop a combination product strategy and determine the lead FDA center via RFD

    A Request for Designation (RFD) is submitted to FDA's Office of Combination Products to determine the lead center and regulatory pathway for combination products.

  6. Which section of the eCTD module contains the Summary of Clinical Safety for an NDA?

    Answer: Module 2.7.4

    Module 2.7.4 of the ICH CTD contains the Summary of Clinical Safety, providing an integrated safety analysis across trials.

  7. A sponsor receives a Refuse to File (RTF) letter from FDA after NDA submission. What does this indicate?

    Answer: The NDA is incomplete or does not meet threshold requirements for substantive review

    An RTF letter means FDA determined the application does not meet minimum completeness standards to allow a substantive review to begin.