US registration process MCQs With Answer

US Registration Process MCQs With Answer for M. Pharm students are designed to strengthen your command over FDA pathways, documentation, timelines, and compliance obligations that drive U.S. drug approvals. This quiz distills key elements of the IND, NDA, ANDA, and BLA systems; eCTD structure; expedited programs (Fast Track, Breakthrough, Priority Review, Accelerated Approval); exclusivities; DMFs; advertising submissions; and critical post-approval reporting. Each question targets high‑yield regulatory decision points you will encounter in coursework, research, and industry practice. Use these MCQs to test your recall of forms, modules, legal citations (505(b)(2), 505(j), 351(k)), and operational requirements like U.S. Agent designation, SPL listings, and FAR timelines—essentials for succeeding in Regulatory Affairs (MPH 104T).

Q1. Which U.S. pathway is used for generic drug approval?

• 505(b)(1) New Drug Application
• 505(b)(2) New Drug Application
• 505(j) Abbreviated New Drug Application (ANDA)
• 351(a) Biologics License Application (BLA)

Correct Answer: 505(j) Abbreviated New Drug Application (ANDA)

Q2. Which FDA form is used to submit an Investigational New Drug (IND) application?

• Form FDA 356h
• Form FDA 1571
• Form FDA 2253
• Form FDA 3500A

Correct Answer: Form FDA 1571

Q3. In eCTD, which module contains clinical study reports?

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

Correct Answer: Module 5 – Clinical Study Reports

Q4. What is the FDA’s standard safety review period after an original IND submission before a clinical trial may proceed?

• 7 days
• 15 days
• 30 days
• 60 days

Correct Answer: 30 days

Q5. A Pre-IND meeting is categorized under which FDA meeting type?

• Type A
• Type B
• Type C
• Type D

Correct Answer: Type B

Q6. The first ANDA filer with a Paragraph IV certification may be eligible for which exclusivity?

• 5-year New Chemical Entity exclusivity
• 3-year new clinical investigation exclusivity
• 7-year Orphan Drug exclusivity
• 180-day generic drug exclusivity

Correct Answer: 180-day generic drug exclusivity

Q7. Which expedited program provides intensive FDA guidance and organizational commitment, plus rolling review, for products showing substantial improvement over existing therapies?

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

Correct Answer: Breakthrough Therapy designation

Q8. In the U.S., Orphan Drug designation confers how many years of marketing exclusivity upon approval?

• 3 years
• 5 years
• 7 years
• 10 years

Correct Answer: 7 years

Q9. The legal pathway for biosimilar approval in the U.S. is defined under which section?

• 505(b)(2) of the FD&C Act
• 351(a) of the Public Health Service Act
• 351(k) of the Public Health Service Act
• 505(j) of the FD&C Act

Correct Answer: 351(k) of the Public Health Service Act

Q10. What is a key requirement for a foreign drug establishment that markets products in the U.S.?

• Obtain a CE mark
• Designate a U.S. Agent and complete establishment registration
• Submit a Device Master File (DMF)
• Only list patents in the Orange Book

Correct Answer: Designate a U.S. Agent and complete establishment registration

Q11. Which Drug Master File (DMF) Type is used for drug substances and drug substance intermediates?

• Type II – Drug substance, drug substance intermediate
• Type III – Packaging material
• Type IV – Excipient
• Type V – FDA-accepted reference information

Correct Answer: Type II – Drug substance, drug substance intermediate

Q12. Which form serves as the common application form for NDA, ANDA, and BLA submissions?

• FDA Form 356h – Application to Market a New or Abbreviated New Drug or Biologic
• FDA Form 1572 – Statement of Investigator
• FDA Form 3674 – ClinicalTrials.gov Certification
• FDA Form 3454 – Financial Disclosure by Clinical Investigators

Correct Answer: FDA Form 356h – Application to Market a New or Abbreviated New Drug or Biologic

Q13. Approval based on a surrogate endpoint reasonably likely to predict clinical benefit is granted under which pathway?

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

Correct Answer: Accelerated Approval

Q14. For products approved under NDA/ANDA, a Field Alert Report (FAR) must be submitted within what timeframe after the applicant becomes aware of a problem?

• Within 24 hours
• Within 3 calendar days
• Within 3 working days
• Within 15 calendar days

Correct Answer: Within 3 working days

Q15. Under Priority Review, FDA’s review goal date for original NDA/BLA applications is generally reduced to:

• 4 months
• 6 months
• 8 months
• 10 months

Correct Answer: 6 months

Q16. To gain approval, an ANDA must primarily demonstrate:

• Bioequivalence to the RLD and sameness of active ingredient, dosage form, strength, and route
• Superiority to the RLD in clinical outcomes
• Novel mechanism and proprietary formulation
• Only CMC equivalence without in vivo studies

Correct Answer: Bioequivalence to the RLD and sameness of active ingredient, dosage form, strength, and route

Q17. Which FDA form is used to submit promotional labeling and advertisements at the time of first use?

• Form FDA 2253 – Transmittal of Advertisements and Promotional Labeling
• Form FDA 3500A – Mandatory MedWatch
• Form FDA 1571 – IND Application
• Form FDA 3674 – ClinicalTrials.gov Certification

Correct Answer: Form FDA 2253 – Transmittal of Advertisements and Promotional Labeling

Q18. In the Orange Book, which Therapeutic Equivalence (TE) code indicates substitutable generic products?

• AB
• BX
• BC
• BD

Correct Answer: AB

Q19. A major post-approval CMC change for an NDA product that could significantly affect quality typically requires which submission type?

• CBE-0 supplement
• CBE-30 supplement
• Prior Approval Supplement (PAS)
• Annual report

Correct Answer: Prior Approval Supplement (PAS)

Q20. Which electronic format is required for drug listing and labeling submissions to FDA?

• HL7 Structured Product Labeling (SPL)
• eCopy PDF
• E2B(R3) Individual Case Safety Report format
• X12 EDI transaction set

Correct Answer: HL7 Structured Product Labeling (SPL)

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