IND, NDA, ANDA global submissions MCQs With Answer

IND, NDA, ANDA Global Submissions MCQs With Answer

For M. Pharm students specializing in Regulatory Affairs (MPH 104T), mastering the pathways of Investigational New Drug (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA) is essential for effective drug development strategies. This MCQ set covers critical concepts such as regulatory objectives, dossier structures (CTD/eCTD), timelines, data requirements, exclusivity and patent certifications, bioequivalence standards, global submission variations, and lifecycle management. You will also encounter practical elements like FDA forms, meeting types, safety reporting, and EU/Japan/Canada equivalents. Designed to strengthen exam readiness and industry competence, these questions emphasize applied understanding over rote memorization, helping you connect regulatory principles to real-world submissions and strategic decision-making across different markets.

Q1. What is the primary objective of an IND in the United States?

• To obtain marketing authorization for a new drug
• To allow human clinical trials to begin in the US after FDA’s 30-day safety review
• To certify patent status in the Orange Book
• To gain 180-day exclusivity for a generic

Correct Answer: To allow human clinical trials to begin in the US after FDA’s 30-day safety review

Q2. Which of the following is not part of an initial IND submission package?

• Investigator’s Brochure
• Clinical protocol(s) and informed consent documentation
• CMC information adequate to support clinical supply
• FDA Form 356h

Correct Answer: FDA Form 356h

Q3. Which IND type provides expanded access to an investigational drug for serious or life-threatening conditions outside clinical trials?

• Investigator IND
• Emergency Use IND
• Treatment IND (Expanded Access)
• Exploratory (Phase 0) IND

Correct Answer: Treatment IND (Expanded Access)

Q4. Under section 505 of the FD&C Act, which pathway relies partly on literature or third-party data and typically requires bridging studies?

• 505(b)(1)
• 505(b)(2)
• 505(j)
• Supplemental NDA (sNDA)

Correct Answer: 505(b)(2)

Q5. The core evidentiary requirement unique to an ANDA is:

• Demonstration of clinical efficacy versus placebo
• Demonstration of bioequivalence to the Reference Listed Drug (RLD)
• Complete nonclinical toxicology program
• Comparative efficacy trial versus originator

Correct Answer: Demonstration of bioequivalence to the Reference Listed Drug (RLD)

Q6. In the CTD/eCTD structure, which module is region-specific and contains administrative information?

• Module 1
• Module 2
• Module 3
• Module 5

Correct Answer: Module 1

Q7. Under PDUFA, what is the typical review goal for a standard NDA?

• 6 months from submission
• 10 months from the 60-day filing date
• 12 months from filing
• 18 months from submission

Correct Answer: 10 months from the 60-day filing date

Q8. Which condition qualifies a generic applicant for 180-day exclusivity?

• Filing a complete ANDA with a Paragraph II certification
• Being the first applicant to file a substantially complete ANDA with a Paragraph IV certification
• Submitting a citizen petition prior to the ANDA
• Obtaining a tentative approval before the RLD patent expires

Correct Answer: Being the first applicant to file a substantially complete ANDA with a Paragraph IV certification

Q9. In an ANDA, which patent certification asserts that listed patents are invalid, unenforceable, or will not be infringed?

• Paragraph I
• Paragraph II
• Paragraph III
• Paragraph IV

Correct Answer: Paragraph IV

Q10. Which FDA publication lists RLDs, therapeutic equivalence codes (TE), and patent/exclusivity information for small-molecule drugs?

• Purple Book
• Federal Register
• Orange Book
• Pharmacopeial Forum

Correct Answer: Orange Book

Q11. For BCS-based biowaivers in ANDA submissions, which classes are generally eligible under FDA guidance, assuming appropriate dissolution and formulation sameness?

• Class I only
• Class III only
• Class I and, in certain cases, Class III
• Class II and Class IV

Correct Answer: Class I and, in certain cases, Class III

Q12. Under IND safety reporting, what are the standard timelines for serious, unexpected suspected adverse reactions (SUSARs)?

• Within 24 hours for all SUSARs
• 7 calendar days for unexpected fatal or life-threatening SUSARs; 15 calendar days for other serious, unexpected SUSARs
• 15 business days for all SUSARs
• 30 calendar days for all SUSARs

Correct Answer: 7 calendar days for unexpected fatal or life-threatening SUSARs; 15 calendar days for other serious, unexpected SUSARs

Q13. In the NDA process, what is the purpose of the Day-74 letter?

• It grants marketing approval
• It requests all postmarketing commitments
• It communicates acceptance for filing, review designation, and major review issues/PDUFA goal date
• It issues a complete response decision

Correct Answer: It communicates acceptance for filing, review designation, and major review issues/PDUFA goal date

Q14. Which situation could lead FDA to issue a Refuse-to-File (RTF) decision for an NDA?

• Too many modules in eCTD
• Proposed proprietary name not finalized
• Lack of stability data adequate to support the proposed shelf life
• Absence of a REMS proposal for a low-risk drug

Correct Answer: Lack of stability data adequate to support the proposed shelf life

Q15. What is the EU counterpart to the US IND for starting clinical trials?

• Market Authorization Application (MAA)
• Clinical Trial Application (CTA) to the National Competent Authority and Ethics Committee
• Scientific Advice request at EMA
• Paediatric Investigation Plan (PIP) submission

Correct Answer: Clinical Trial Application (CTA) to the National Competent Authority and Ethics Committee

Q16. In Japan, which body conducts the scientific review of NDAs?

• EMA
• PMDA, with approval by MHLW
• MHRA
• TGA

Correct Answer: PMDA, with approval by MHLW

Q17. In Canada, the regulatory pathway analogous to a US ANDA is called:

• New Drug Submission (NDS)
• Supplemental New Drug Submission (SNDS)
• Abbreviated New Drug Submission (ANDS)
• Clinical Trial Application (CTA)

Correct Answer: Abbreviated New Drug Submission (ANDS)

Q18. In eCTD lifecycle management, submissions are organized as:

• A single cumulative PDF per module
• A numbered sequence with lifecycle operators (new/replace/delete) and an XML backbone
• Paper volumes mirrored electronically
• One dossier per study

Correct Answer: A numbered sequence with lifecycle operators (new/replace/delete) and an XML backbone

Q19. Which FDA quality review framework guides Module 3 expectations in ANDA submissions?

• QMSR
• QbR (Question-based Review)
• QPSR
• QP1A

Correct Answer: QbR (Question-based Review)

Q20. Which FDA form accompanies marketing applications such as NDAs and ANDAs?

• FDA Form 1571
• FDA Form 1572
• FDA Form 356h
• FDA Form 2253

Correct Answer: FDA Form 356h

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