Regulatory approval processes: IND, NDA, ANDA, SNDA in US MCQs With Answer

Introduction

This quiz set focuses on regulatory approval processes in the United States — IND, NDA, ANDA and SNDA — tailored for M. Pharm students preparing for Regulatory Aspects of Drugs & Cosmetics (MRA201T). It covers definitions, application types, review timelines, exclusivities, patent certifications under Hatch‑Waxman, bioequivalence concepts, and FDA enforcement tools such as clinical holds and supplemental application categories. Questions range from conceptual foundations to practical regulatory choices that influence drug development strategy, generic competition and post‑approval changes. Use these MCQs to test comprehension of statutory pathways, submission content expectations, key regulatory terminology and the strategic implications of filing choices in US regulatory practice.

Q1. What is the primary purpose of submitting an Investigational New Drug (IND) application to the FDA?

• To obtain marketing approval for a new drug product
• To register a manufacturing facility with the FDA
• To allow clinical testing of an investigational drug in humans and interstate shipment
• To request orphan drug designation

Correct Answer: To allow clinical testing of an investigational drug in humans and interstate shipment

Q2. Which of the following is NOT a recognized type of IND?

• Commercial IND
• Investigator IND
• Emergency (single‑patient) IND
• Biologics License Application (BLA)

Correct Answer: Biologics License Application (BLA)

Q3. What does an FDA clinical hold represent?

• An approval to proceed with expanded patient access
• An order to delay or suspend a clinical investigation
• A voluntary pause requested by the sponsor for operational reasons
• A notice of complete application acceptance

Correct Answer: An order to delay or suspend a clinical investigation

Q4. Which statutory provision covers a full New Drug Application (NDA) that relies on the applicant’s own safety and effectiveness data?

• Section 505(b)(1)
• Section 505(j)
• Section 505(b)(2)
• Section 351(k)

Correct Answer: Section 505(b)(1)

Q5. What best describes a 505(b)(2) NDA?

• An application exclusively for generic drugs relying entirely on reference product data
• An NDA that relies in part on studies not conducted by the applicant or on published literature
• A biologics license application for a biosimilar
• An emergency use authorization request

Correct Answer: An NDA that relies in part on studies not conducted by the applicant or on published literature

Q6. What is the primary purpose of an Abbreviated New Drug Application (ANDA)?

• To seek approval for a novel chemical entity with full clinical data
• To request an orphan drug exclusivity
• To seek approval of a generic drug based on demonstrated bioequivalence to a reference listed drug
• To apply for a pediatric exclusivity extension

Correct Answer: To seek approval of a generic drug based on demonstrated bioequivalence to a reference listed drug

Q7. Under Hatch‑Waxman, what does a Paragraph IV certification assert?

• The referenced patent is valid and will be respected
• The generic product is therapeutically superior to the reference product
• The patent is invalid or will not be infringed by the proposed generic product
• The applicant requests a patent extension

Correct Answer: The patent is invalid or will not be infringed by the proposed generic product

Q8. Who is eligible for the 180‑day exclusivity under the Hatch‑Waxman framework?

• The first applicant to file an ANDA with a Paragraph IV certification and meet statutory requirements
• Any ANDA applicant approved within the first year
• The original NDA holder upon first approval
• All ANDA applicants that demonstrate bioequivalence within six months

Correct Answer: The first applicant to file an ANDA with a Paragraph IV certification and meet statutory requirements

Q9. What type of information is contained in the FDA’s “Orange Book”?

• All IND submissions currently under review
• Approved drug products with therapeutic equivalence evaluations and patent/exclusivity information
• Clinical trial protocols for ongoing Phase III studies
• FDA inspection reports for manufacturing facilities

Correct Answer: Approved drug products with therapeutic equivalence evaluations and patent/exclusivity information

Q10. What is a Supplemental New Drug Application (SNDA)?

• An application filed to seek an initial marketing approval for a new chemical entity
• An application submitted to FDA to request changes to an already approved NDA
• A pathway for generic drug approval based on bioequivalence
• A request for an investigational exemption to export an unapproved drug

Correct Answer: An application submitted to FDA to request changes to an already approved NDA

Q11. Which type of supplement may, under specified circumstances, be implemented by the sponsor before FDA approval?

• Prior Approval Supplement (PAS)
• Annual Report
• Changes Being Effected (CBE) supplement
• Original NDA

Correct Answer: Changes Being Effected (CBE) supplement

Q12. Which regulatory pathway is primarily used to seek approval for biosimilar products in the US?

• ANDA under Section 505(j)
• NDA under Section 505(b)(1)
• BLA under Section 351(k)
• 505(b)(2) NDA

Correct Answer: BLA under Section 351(k)

Q13. What is the most common study design used to demonstrate bioequivalence in an ANDA submission?

• Randomized parallel group in patients with active disease
• Randomized two‑period, two‑sequence crossover study in healthy volunteers
• Open‑label single arm study in healthy volunteers
• Longitudinal cohort study in multiple centers

Correct Answer: Randomized two‑period, two‑sequence crossover study in healthy volunteers

Q14. Which of the following is generally NOT required in an ANDA submission?

• Demonstration of bioequivalence to the reference listed drug
• Full clinical safety and efficacy trials
• Chemistry, manufacturing and controls (CMC) information
• Labeling that is the same as the reference product with permitted differences

Correct Answer: Full clinical safety and efficacy trials

Q15. How long is New Chemical Entity (NCE) exclusivity granted by FDA for an approved NDA?

• 1 year
• 3 years
• 5 years
• 7 years

Correct Answer: 5 years

Q16. Which supplement type is generally required for major manufacturing changes that may affect product quality and require FDA review before implementation?

• Changes Being Effected (CBE) supplement
• Prior Approval Supplement (PAS)
• Annual Report
• Abbreviated New Drug Application (ANDA)

Correct Answer: Prior Approval Supplement (PAS)

Q17. Under FDA PDUFA performance goals, what is the typical target review time for a Priority NDA?

• 3 months
• 6 months
• 10 months
• 18 months

Correct Answer: 6 months

Q18. Which major effect resulted from the Hatch‑Waxman Amendments?

• Elimination of patent protections for all pharmaceuticals
• Creation of a formal ANDA pathway and mechanisms for patent challenges tied to generic approvals
• Transfer of NDA authority from FDA to USPTO
• Requirement that all generics undergo full Phase III trials

Correct Answer: Creation of a formal ANDA pathway and mechanisms for patent challenges tied to generic approvals

Q19. What does the abbreviation “SNDA” stand for?

• Significant New Drug Authorization
• Supplemental New Drug Application
• Summary Notice of Drug Approval
• Safety Notice for Drug Administration

Correct Answer: Supplemental New Drug Application

Q20. What is the primary objective of a Phase I clinical trial under an IND?

• To demonstrate long‑term efficacy in large patient populations
• To assess safety, tolerability and pharmacokinetics in a small number of healthy volunteers or patients
• To compare the investigational product with marketed therapies in randomized trials
• To obtain marketing approval from FDA

Correct Answer: To assess safety, tolerability and pharmacokinetics in a small number of healthy volunteers or patients

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