New Drug Application (NDA) informational content MCQs With Answer

Introduction

This blog provides targeted multiple-choice questions on New Drug Application (NDA) information tailored for M.Pharm students studying Product Development and Technology Transfer. The questions focus on regulatory pathways, dossier structure (CTD/eCTD), CMC requirements, clinical and nonclinical data expectations, review designations, postmarketing obligations, exclusivities, and practical submission strategies. Each MCQ is designed to deepen conceptual understanding and prepare students for examinations and regulatory roles in pharmaceutical development. Answers are provided to support self-assessment and reinforce key concepts needed for preparing and evaluating NDA submissions in real-world regulatory environments.

Q1. What is the primary purpose of submitting a New Drug Application (NDA) to the US FDA?

• To request approval to market a new drug for a specific indication in the United States
• To obtain permission to start first-in-human clinical trials
• To register a generic copy of an approved reference drug
• To license a biological product derived from living cells

Correct Answer: To request approval to market a new drug for a specific indication in the United States

Q2. Which document structure is commonly used for modern NDA submissions to organize modules of information?

• Common Technical Document (CTD) Modules 1–5
• International Submission Package (ISP) Modules A–D
• Biologics License Format (BLF) Sections I–IV
• ANDA Master File Structure (AMS) Parts 1–4

Correct Answer: Common Technical Document (CTD) Modules 1–5

Q3. The 505(b)(2) NDA regulatory pathway is best described as which of the following?

• An application that relies in part on published literature or the FDA’s findings of safety and/or effectiveness for a previously approved drug
• An abbreviated application that only requires bioequivalence data
• An application exclusively for biological products
• An emergency use authorization for unapproved drugs

Correct Answer: An application that relies in part on published literature or the FDA’s findings of safety and/or effectiveness for a previously approved drug

Q4. Under typical PDUFA goals, what is the FDA review target timeframe for a standard (non-priority) NDA review?

• 10 months from filing
• 6 months from filing
• 2 years from filing
• 30 days from submission

Correct Answer: 10 months from filing

Q5. What does the abbreviation eCTD stand for in the context of electronic regulatory submissions?

• electronic Common Technical Document
• electronic Clinical Trial Dossier
• enhanced Chemical and Technical Data
• electronic Certification of Therapeutic Drugs

Correct Answer: electronic Common Technical Document

Q6. Which NDA section primarily addresses drug substance and drug product manufacturing, controls, and stability?

• Module 3 – Quality (CMC)
• Module 4 – Nonclinical Study Reports
• Module 5 – Clinical Study Reports
• Module 1 – Administrative and Labeling Information

Correct Answer: Module 3 – Quality (CMC)

Q7. What is the main objective of a REMS (Risk Evaluation and Mitigation Strategy) associated with an NDA?

• To ensure that the benefits of a drug outweigh its risks by implementing specific risk minimization measures
• To extend patent protection for the drug by 5 years
• To fast-track the review of the NDA
• To provide automatic orphan drug exclusivity

Correct Answer: To ensure that the benefits of a drug outweigh its risks by implementing specific risk minimization measures

Q8. What is the role of an FDA advisory committee in the NDA review process?

• To provide independent expert advice and recommendations that are non-binding to the FDA
• To issue the final approval decision for the NDA
• To prepare the eCTD submission on behalf of the sponsor
• To conduct the clinical trials required for the NDA

Correct Answer: To provide independent expert advice and recommendations that are non-binding to the FDA

Q9. Which study primarily measures the rate and extent of a drug’s absorption in humans?

• Bioavailability study
• Toxicology study
• Pharmacovigilance study
• Stability study

Correct Answer: Bioavailability study

Q10. Under US regulations, which legislative requirement mandates pediatric assessment for certain NDAs unless a waiver or deferral is granted?

• Pediatric Research Equity Act (PREA)
• Orphan Drug Act
• PDUFA
• Hatch-Waxman Act

Correct Answer: Pediatric Research Equity Act (PREA)

Q11. What regulatory incentive grants seven years of marketing exclusivity in the US for qualifying drugs?

• Orphan drug designation
• First-to-file generic exclusivity
• Priority review voucher
• Pediatric exclusivity

Correct Answer: Orphan drug designation

Q12. Which designation is intended to expedite development and review of drugs for serious conditions with unmet medical need?

• Fast Track designation
• ANDA certification
• Biologics License Amendment
• Abbreviated New Drug Application

Correct Answer: Fast Track designation

Q13. What does a “rolling review” allow a sponsor to do during NDA submission?

• Submit sections of the application (modules) to the FDA as they become ready rather than waiting for a complete dossier
• Receive immediate marketing authorization without review
• Merge multiple NDAs from different sponsors into one file
• Convert an ANDA into an NDA automatically

Correct Answer: Submit sections of the application (modules) to the FDA as they become ready rather than waiting for a complete dossier

Q14. The user fee paid by sponsors to support NDA review under PDUFA is commonly called:

• PDUFA fee
• ANDA fee
• BLA surcharge
• CTD filing charge

Correct Answer: PDUFA fee

Q15. Which postmarketing obligation is legally enforceable and may require specific studies or trials?

• Postmarketing requirement (PMR)
• Voluntary postmarketing commitment (PMC)
• Labeling change request
• Phase I exploratory study

Correct Answer: Postmarketing requirement (PMR)

Q16. Which ICH guideline is primarily used for designing stability testing required in the NDA Module 3?

• ICH Q1A (Stability Testing of New Drug Substances and Products)
• ICH Q2 (Analytical Validation)
• ICH Q3 (Impurities)
• ICH Q5C (Biotechnological Products)

Correct Answer: ICH Q1A (Stability Testing of New Drug Substances and Products)

Q17. Which application type is appropriate for licensing a biological product rather than a small-molecule new drug?

• Biologics License Application (BLA)
• New Drug Application (NDA)
• Abbreviated New Drug Application (ANDA)
• Investigational New Drug (IND) Application

Correct Answer: Biologics License Application (BLA)

Q18. The 180-day exclusivity period is associated with which regulatory scenario?

• The first approved ANDA applicant that successfully challenges patent(s) under Hatch-Waxman
• An orphan drug’s market exclusivity
• Priority review voucher redemption
• Pediatric exclusivity awarded after FDA review

Correct Answer: The first approved ANDA applicant that successfully challenges patent(s) under Hatch-Waxman

Q19. Which CTD module contains full clinical study reports and aggregated clinical data?

• Module 5 – Clinical Study Reports and Summaries
• Module 1 – Administrative Information
• Module 2 – Quality Summaries
• Module 3 – Chemical, Manufacturing and Controls

Correct Answer: Module 5 – Clinical Study Reports and Summaries

Q20. In the context of the NDA, what is the primary focus of the Chemistry, Manufacturing and Controls (CMC) documentation?

• Product composition, manufacturing process, in-process controls, specifications, and stability supporting consistent quality
• Clinical efficacy endpoints and statistical analysis plans
• Nonclinical toxicology and safety pharmacology data
• Marketing strategy and commercial pricing information

Correct Answer: Product composition, manufacturing process, in-process controls, specifications, and stability supporting consistent quality

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