FDA regulations CFR 21 Part 50, 54, 312, 314 MCQs With Answer

Introduction

Understanding 21 CFR Parts 50, 54, 312 and 314 is essential for M.Pharm students specializing in clinical research and regulatory affairs. These FDA regulations govern the protection of human subjects and informed consent (Part 50), disclosure of financial interests by clinical investigators (Part 54), investigational new drug (IND) applications and sponsor/investigator obligations (Part 312), and the content, review and approval of new drug applications (NDAs) and post‑approval requirements (Part 314). Mastery of these rules helps pharmacists design compliant trials, prepare regulatory submissions, ensure participant safety, manage conflicts of interest, and navigate approval and post‑marketing obligations — all critical skills for modern drug development.

Q1. Which of the following is explicitly listed in 21 CFR Part 50 as a required element of informed consent?

• A description of the procedures to be followed, including identification of any procedures which are experimental
• A statement that participation guarantees direct therapeutic benefit
• The investigator’s personal contact details for future employment
• A guarantee of complete confidentiality with no exceptions

Correct Answer: A description of the procedures to be followed, including identification of any procedures which are experimental

Q2. Under 21 CFR 50.24, which condition allows an exception from informed consent for emergency research?

• Life‑threatening condition, inability to obtain consent, potential direct benefit to subjects, and required community consultation and public disclosure
• Non‑emergency outpatient trials where consent is impractical
• Any study involving minimal risk only
• When a family member gives oral consent without documentation

Correct Answer: Life‑threatening condition, inability to obtain consent, potential direct benefit to subjects, and required community consultation and public disclosure

Q3. Who is required to provide financial disclosure under 21 CFR Part 54?

• Clinical investigators involved in the study
• Only the sponsor’s CEO
• The FDA reviewer assigned to the application
• All clinical trial subjects

Correct Answer: Clinical investigators involved in the study

Q4. Per FDA guidance referenced in 21 CFR Part 54, which financial interest is typically considered “significant” requiring disclosure?

• Ownership or equity interest exceeding $50,000 in value or more than 5% ownership
• A travel reimbursement under $100
• Any gift of promotional pens
• Stock options valued at $1,000 or less

Correct Answer: Ownership or equity interest exceeding $50,000 in value or more than 5% ownership

Q5. Which of the following is a required component of an IND submission under 21 CFR Part 312?

• Protocol, investigator’s brochure, and manufacturing information (chemistry, manufacturing and controls)
• Only a brief synopsis of the study without any manufacturing data
• A signed sales contract with distributors
• Copies of all marketing materials planned post‑approval

Correct Answer: Protocol, investigator’s brochure, and manufacturing information (chemistry, manufacturing and controls)

Q6. What is the primary purpose of FDA Form 1571 in the IND process?

• To provide sponsor attestation and administrative information for an IND submission
• To register each clinical trial subject
• To report adverse events directly to investigators
• To request expedited review of an NDA

Correct Answer: To provide sponsor attestation and administrative information for an IND submission

Q7. Who has the authority to place an IND on clinical hold according to 21 CFR Part 312?

• The FDA (e.g., CDER) based on safety or protocol concerns
• An institutional IRB without notifying the FDA
• The trial’s contract research organization (CRO) alone
• The study’s sponsor automatically at any time without cause

Correct Answer: The FDA (e.g., CDER) based on safety or protocol concerns

Q8. Under 21 CFR 312.32, within what time frame must a sponsor report a serious and unexpected suspected adverse reaction to FDA?

• Within 15 calendar days for serious and unexpected suspected adverse reactions (7 days if fatal or life‑threatening)
• Only in the annual report
• Within 90 days of the event
• Only after study completion

Correct Answer: Within 15 calendar days for serious and unexpected suspected adverse reactions (7 days if fatal or life‑threatening)

Q9. When must sponsors submit the IND annual report as required by 21 CFR Part 312?

• Within 60 days of the anniversary date of the IND
• Within 6 months of the anniversary date
• Only when the sponsor decides to file an NDA
• Every two years regardless of IND status

Correct Answer: Within 60 days of the anniversary date of the IND

Q10. 21 CFR Part 314 primarily governs which aspect of drug regulation?

• The content, submission, review, and approval of new drug applications (NDAs)
• Dietary supplement labeling only
• Manufacturing practices for medical devices
• State pharmacy licensing requirements

Correct Answer: The content, submission, review, and approval of new drug applications (NDAs)

Q11. According to 21 CFR 314.50, NDAs must contain clinical data demonstrating what?

• Safety and effectiveness from adequate and well‑controlled investigations
• Only a single patient case report
• Marketing projections and sales forecasts
• Investigator personal financial records

Correct Answer: Safety and effectiveness from adequate and well‑controlled investigations

Q12. Under 21 CFR Part 314, a prior approval supplement to an approved NDA is required when which type of change is proposed?

• A change that could significantly affect the safety or effectiveness of the drug
• Minor editorial changes to the labeling with no safety impact
• Routine annual updates to the company’s organizational chart
• Changes in the color of the office logo

Correct Answer: A change that could significantly affect the safety or effectiveness of the drug

Q13. Which regulatory submission is used to seek approval for a generic version of a previously approved drug?

• An Abbreviated New Drug Application (ANDA)
• An original full NDA with new clinical efficacy trials
• An Investigational New Drug (IND) application
• A 510(k) premarket notification

Correct Answer: An Abbreviated New Drug Application (ANDA)

Q14. Under 21 CFR 314.80, marketing applicants must report serious and unexpected adverse drug experiences to FDA within what time frame?

• Within 15 calendar days of receipt of the information
• Only in the periodic adverse event summary every five years
• Within 90 days after the end of the quarter
• Only if the event becomes public knowledge

Correct Answer: Within 15 calendar days of receipt of the information

Q15. Which of the following best describes an IRB’s responsibilities under 21 CFR Part 50 and related regulations?

• Review and approve research protocols, ensure informed consent is obtained, and monitor subject protection
• Serve as the sponsor’s marketing advisory board
• Manufacture investigational drugs for clinical trials
• Audit only the sponsor’s financial statements

Correct Answer: Review and approve research protocols, ensure informed consent is obtained, and monitor subject protection

Q16. Failure to disclose material financial interests by investigators under 21 CFR Part 54 can lead the FDA to do which of the following?

• Refuse to file or approve the application until concerns are resolved
• Automatically approve the application without review
• Delegate the review to the investigator
• Ignore the omission if the data are otherwise adequate

Correct Answer: Refuse to file or approve the application until concerns are resolved

Q17. Under 21 CFR Part 312, which is a primary responsibility of the clinical investigator?

• Protect the rights, safety, and welfare of subjects and ensure the study is conducted according to the signed protocol
• Set the drug price post‑approval
• Approve the sponsor’s marketing plan
• Determine the FDA review timelines

Correct Answer: Protect the rights, safety, and welfare of subjects and ensure the study is conducted according to the signed protocol

Q18. Which document is specifically required as part of an IND submission to inform investigators about the investigational product?

• The Investigator’s Brochure
• The sponsor’s annual corporate tax return
• A letter of intent to market after approval
• A summary of competitor products’ prices

Correct Answer: The Investigator’s Brochure

Q19. Under 21 CFR Part 50 Subpart D, what is required when enrolling children in clinical research?

• Obtain the permission of parents or guardians and obtain the child’s assent when the child is capable of providing it
• Only the child’s verbal agreement is sufficient regardless of age
• Parental permission is never required for minimal risk studies
• Children cannot participate under any circumstances

Correct Answer: Obtain the permission of parents or guardians and obtain the child’s assent when the child is capable of providing it

Q20. What is the primary objective of Phase 1 clinical trials as recognized in FDA regulations and guidance (21 CFR Part 312 context)?

• To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in a small number of subjects
• To determine long‑term effectiveness in thousands of patients
• To obtain marketing approval without clinical data
• To finalize post‑marketing surveillance plans

Correct Answer: To evaluate safety, tolerability, pharmacokinetics and pharmacodynamics in a small number of subjects

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