CRA CRA Regulatory Submissions & FDA Requirements 2 — Questions and Answers
Question 1: Under 21 CFR Part 312, how long must a sponsor retain IND records after the drug is no longer under investigation?
- 2 years (Correct answer)
- 5 years
- 10 years
- The records must be kept indefinitely
Correct answer: 2 years
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?
- Type A Meeting
- Type B Pre-NDA/BLA Meeting (Correct answer)
- Type C Meeting
- End-of-Phase 1 Meeting
Correct answer: Type B Pre-NDA/BLA Meeting
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?
- To describe the investigator's qualifications
- To provide a comprehensive integrated description of study methods and results (Correct answer)
- To outline the manufacturing process of the drug
- To summarize preclinical toxicology findings
Correct answer: To provide a comprehensive integrated description of study methods and results
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?
- Accelerated Approval
- Breakthrough Therapy Designation
- Fast Track Designation (Correct answer)
- Rolling Review
Correct answer: Fast Track Designation
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?
- Submit a final report within 6 months
- Notify the FDA in writing within 30 days (Correct answer)
- Archive all records with a third party
- Only notify the participating investigators
Correct answer: Notify the FDA in writing within 30 days
Per 21 CFR Part 312.38, a sponsor must notify the FDA in writing within 30 days if an IND clinical investigation is discontinued.
Question 6: What is the regulatory purpose of a Form FDA 1572 (Statement of Investigator)?
- To authorize the manufacture of an investigational drug
- To commit the investigator to comply with FDA regulations and conduct the study as approved (Correct answer)
- To request an IND from the FDA
- To report serious adverse events to the sponsor
Correct answer: To commit the investigator to comply with FDA regulations and conduct the study as approved
Form FDA 1572 is a legally binding commitment by the principal investigator to comply with FDA regulations and conduct the study as described in the protocol.
CRA CRA Regulatory Submissions & FDA Requirements 2
Under 21 CFR Part 312, how long must a sponsor retain IND records after the drug is no longer under investigation?