CTA Regulatory Submissions & Approvals 2

Question 1

Which FDA form is used to submit an Investigational New Drug (IND) application?

Accepted Answer

FDA Form 1571

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

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

Answer

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?

Accepted Answer

Module 5

Answer

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?

Accepted Answer

Accelerated Approval

Answer

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

(CTA) Clinical Trial Associate Certification Practice Test