CRA CRA Regulatory Submissions & FDA Requirements 2

Question 1

Under 21 CFR Part 312, how long must a sponsor retain IND records after the drug is no longer under investigation?

Accepted Answer

2 years

Answer

Under 21 CFR Part 312.57, sponsors must retain IND records for 2 years after the investigation is discontinued and FDA is notified.

Question 2

Which type of FDA meeting is used specifically to discuss data needed to support a marketing application before it is submitted?

Accepted Answer

Type B Pre-NDA/BLA Meeting

Answer

A Type B Pre-NDA/BLA meeting is held to discuss the data package and any outstanding issues before the sponsor submits a marketing application.

Question 3

What is the primary purpose of a Clinical Study Report (CSR) submitted as part of an NDA?

Accepted Answer

To provide a comprehensive integrated description of study methods and results

Answer

A CSR provides a complete and transparent integrated description of the clinical study's methods, conduct, and results per ICH E3 guidelines.

Question 4

Which FDA pathway is designed to expedite the development and review of drugs that treat serious conditions and fill an unmet medical need?

Accepted Answer

Fast Track Designation

Answer

Fast Track Designation is designed to facilitate the development of drugs for serious conditions that fill an unmet medical need by allowing more frequent FDA interactions.

Question 5

Under FDA regulations, what must a sponsor do if a clinical study is discontinued?

Accepted Answer

Notify the FDA in writing within 30 days

Answer

Per 21 CFR Part 312.38, a sponsor must notify the FDA in writing within 30 days if an IND clinical investigation is discontinued.

(CRA) Certified Research Associate Practice Test

(CRA) Certified Research Associate Practice Test

CRA CRA Regulatory Submissions & FDA Requirements 2