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Regulatory Submissions & Approvals Flashcards

7 cards from real CTA 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 form is used to submit an Investigational New Drug (IND) application?

    Answer: FDA Form 1571

    FDA Form 1571 is the cover sheet required for all IND submissions to the FDA.

  2. What is the purpose of a Type B meeting with the FDA during clinical development?

    Answer: To discuss Phase 2 trial design and endpoints before Phase 3 initiation

    Type B meetings include End-of-Phase 2 and Pre-NDA/BLA meetings used to align on Phase 3 design before pivotal trials.

  3. A sponsor receives a Complete Response Letter (CRL) from the FDA. What does this indicate?

    Answer: The application cannot be approved in its current form and deficiencies must be addressed

    A CRL means the FDA will not approve the application in its present form and outlines issues requiring resolution.

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

    Answer: Module 5

    Module 5 of the CTD contains clinical study reports and individual patient data.

  5. What regulatory pathway allows the FDA to approve a drug based on a surrogate endpoint that is reasonably likely to predict clinical benefit?

    Answer: Accelerated Approval

    Accelerated Approval allows use of surrogate or intermediate endpoints to support earlier drug approval for serious conditions.

  6. Under 21 CFR Part 312, how long does the FDA have to place a clinical hold on a newly submitted IND before trials may proceed?

    Answer: 30 days

    The FDA has 30 days to review a new IND and issue a clinical hold; if no hold is issued, the study may begin.

  7. Which EMA procedure allows a single marketing authorization application to be submitted and reviewed centrally for approval across all EU member states?

    Answer: Centralized Procedure

    The Centralized Procedure is mandatory for certain drug classes and results in a single EMA marketing authorization valid in all EU/EEA countries.