CTA Regulatory Submissions & Approvals 2 — Questions and Answers
Question 1: Which FDA form is used to submit an Investigational New Drug (IND) application?
- FDA Form 1571 (Correct answer)
- FDA Form 356h
- FDA Form 3674
- FDA Form 482
Correct answer: FDA Form 1571
FDA Form 1571 is the cover sheet required for all IND submissions to the FDA.
Question 2: What is the purpose of a Type B meeting with the FDA during clinical development?
- To discuss Phase 2 trial design and endpoints before Phase 3 initiation (Correct answer)
- To review post-market safety data after approval
- To negotiate manufacturing site inspections
- To obtain accelerated approval status
Correct 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.
Question 3: A sponsor receives a Complete Response Letter (CRL) from the FDA. What does this indicate?
- The application cannot be approved in its current form and deficiencies must be addressed (Correct answer)
- The drug has been approved with post-market commitments
- The clinical trial may proceed to the next phase
- The FDA requires an advisory committee meeting before review
Correct 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.
Question 4: Which section of a Common Technical Document (CTD) contains clinical study reports?
- Module 5 (Correct answer)
- Module 2
- Module 3
- Module 4
Correct answer: Module 5
Module 5 of the CTD contains clinical study reports and individual patient data.
Question 5: What regulatory pathway allows the FDA to approve a drug based on a surrogate endpoint that is reasonably likely to predict clinical benefit?
- Accelerated Approval (Correct answer)
- Fast Track designation
- Breakthrough Therapy designation
- Priority Review
Correct answer: Accelerated Approval
Accelerated Approval allows use of surrogate or intermediate endpoints to support earlier drug approval for serious conditions.
Question 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?
- 30 days (Correct answer)
- 60 days
- 14 days
- 45 days
Correct 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.
Question 7: Which EMA procedure allows a single marketing authorization application to be submitted and reviewed centrally for approval across all EU member states?
- Centralized Procedure (Correct answer)
- Mutual Recognition Procedure
- Decentralized Procedure
- National Procedure
Correct 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.
CTA Regulatory Submissions & Approvals 2
Which FDA form is used to submit an Investigational New Drug (IND) application?