NDA approval process MCQs With Answer

NDA Approval Process MCQs With Answer

The New Drug Application (NDA) is the U.S. pathway to market a new drug, integrating evidence on quality, safety, and efficacy for FDA review. For M. Pharm students of Regulatory Affairs (MPH 104T), mastering the NDA process means understanding regulatory frameworks (21 CFR 314), the eCTD structure, user-fee timelines under PDUFA, expedited programs, inspectional expectations, postmarketing commitments, and lifecycle management. This quiz compiles high-yield, exam-focused questions that go beyond basics—covering filing standards, Complete Response Letters, REMS, exclusivity mechanics, and supplement classifications. Each MCQ includes the correct answer to support self-assessment and rapid revision. Use these questions to solidify concepts essential for real-world submissions and competitive exams in regulatory sciences.

Q1. What is the primary purpose of submitting an NDA to the FDA?

• To obtain permission to conduct first-in-human studies
• To demonstrate that a drug is safe, effective, and manufactured with adequate quality controls for U.S. marketing
• To establish international harmonization of clinical data
• To register a manufacturing site with the FDA

Correct Answer: To demonstrate that a drug is safe, effective, and manufactured with adequate quality controls for U.S. marketing

Q2. Which U.S. regulation principally governs NDA content and approval procedures?

• 21 CFR Part 312
• 21 CFR Part 210
• 21 CFR Part 11
• 21 CFR Part 314

Correct Answer: 21 CFR Part 314

Q3. Within what timeframe does FDA decide whether to file an NDA for substantive review after receipt?

• 30 days
• 60 days
• 90 days
• 120 days

Correct Answer: 60 days

Q4. Under PDUFA, what is the standard review goal date for an NDA?

• 6 months
• 8 months
• 10 months
• 12 months

Correct Answer: 10 months

Q5. Under PDUFA, what is the typical review goal for a Priority Review NDA?

• 4 months
• 6 months
• 9 months
• 12 months

Correct Answer: 6 months

Q6. In the eCTD structure for an NDA, which module contains Clinical Study Reports?

• Module 1 (Regional/Administrative)
• Module 2 (Summaries and Overviews)
• Module 3 (Quality/CMC)
• Module 5 (Clinical Study Reports)

Correct Answer: Module 5 (Clinical Study Reports)

Q7. Which eCTD module houses the Quality (CMC) information in an NDA?

• Module 1
• Module 2
• Module 3
• Module 4

Correct Answer: Module 3

Q8. Which FDA form accompanies an NDA as the application form?

• FDA Form 1571
• FDA Form 2253
• FDA Form 356h
• FDA Form 483

Correct Answer: FDA Form 356h

Q9. Which approval pathway permits reliance on published literature or FDA’s prior findings of safety and effectiveness for a drug?

• 505(b)(1) NDA
• 505(b)(2) NDA
• 505(j) ANDA
• Biologics License Application (351(a))

Correct Answer: 505(b)(2) NDA

Q10. If an NDA is administratively incomplete at filing, which FDA action is typically issued?

• Complete Response Letter (CRL)
• Refuse-to-File (RTF) letter
• Warning Letter
• Untitled Letter

Correct Answer: Refuse-to-File (RTF) letter

Q11. What does a Complete Response Letter (CRL) communicate to the applicant?

• Approval of the NDA as submitted
• Rejection of the application with no path forward
• Deficiencies that preclude approval in its current form and required actions
• Scheduling of a Pre-Approval Inspection

Correct Answer: Deficiencies that preclude approval in its current form and required actions

Q12. Which expedited program specifically allows rolling review of NDA sections?

• Priority Review
• Accelerated Approval
• Breakthrough Therapy
• Fast Track designation

Correct Answer: Fast Track designation

Q13. What is the primary role of an FDA Advisory Committee in NDA review?

• To issue binding approval decisions
• To provide independent, non-binding expert recommendations to FDA
• To conduct sponsor’s clinical trials
• To negotiate drug pricing

Correct Answer: To provide independent, non-binding expert recommendations to FDA

Q14. A Risk Evaluation and Mitigation Strategy (REMS) may be required to:

• Accelerate clinical development timelines
• Ensure that the benefits of a drug outweigh its risks through targeted risk controls
• Replace standard labeling requirements
• Waive manufacturing inspections

Correct Answer: Ensure that the benefits of a drug outweigh its risks through targeted risk controls

Q15. The main objective of a Pre-Approval Inspection (PAI) in the NDA process is to:

• Verify the sponsor’s financial disclosures
• Assess facility readiness, data integrity, and conformance to cGMP for the proposed commercial process
• Approve the drug’s proprietary name
• Certify distribution channels

Correct Answer: Assess facility readiness, data integrity, and conformance to cGMP for the proposed commercial process

Q16. New Chemical Entity (NCE) exclusivity in the U.S. generally provides how many years of protection from certain generic submissions?

• 3 years
• 5 years
• 7 years
• 12 years

Correct Answer: 5 years

Q17. For a newly approved NDA, what is the typical U.S. schedule for Periodic Adverse Drug Experience Reports (PADERs)?

• Monthly for 2 years, then quarterly
• Quarterly for the first 3 years, then annually thereafter
• Annually only
• Biennially only

Correct Answer: Quarterly for the first 3 years, then annually thereafter

Q18. Which post-approval change category requires FDA approval before implementation?

• Changes Being Effected in 0 days (CBE-0)
• Changes Being Effected in 30 days (CBE-30)
• Prior Approval Supplement (PAS)
• Annual Report (AR)

Correct Answer: Prior Approval Supplement (PAS)

Q19. Which FDA reference lists approved drugs along with patent and exclusivity information relevant to NDA products?

• Purple Book
• Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
• Red Book
• Green Book

Correct Answer: Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Q20. Under PREA, the Initial Pediatric Study Plan (iPSP) for an NDA is generally due:

• At the time of NDA submission
• No later than 60 days after the end-of-Phase 2 (EOP2) meeting
• Before first-in-human dosing
• 12 months after NDA approval

Correct Answer: No later than 60 days after the end-of-Phase 2 (EOP2) meeting

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