US FDA IND, NDA 505(b)(1), 505(b)(2) MCQs With Answer

Introduction: This quiz set on US FDA IND and NDA pathways (505(b)(1) and 505(b)(2)) is tailored for M.Pharm students preparing for clinical research and regulatory roles. It covers essential regulatory concepts — from IND submission components, clinical holds, sponsor and investigator responsibilities, to differences between full NDAs and hybrid 505(b)(2) applications. Emphasis is placed on when reliance on published literature or third-party data is acceptable, exclusivity, patent certifications, and bridging requirements. These MCQs reinforce deep understanding needed for regulatory filings, strategic development choices, and post‑marketing obligations under US law, helping students apply regulations to real-world drug development scenarios.

Q1. Which component is NOT typically required in an initial IND submission to the FDA?

• Animal pharmacology and toxicology data
• Investigator’s brochure
• Manufacturing information (CMC)
• Pooled postmarketing surveillance reports from other countries

Correct Answer: Pooled postmarketing surveillance reports from other countries

Q2. What is the primary purpose of a clinical hold issued by the FDA on an IND?

• To permanently deny approval of the drug
• To delay IND effective date until additional information is provided to protect human subjects
• To require payment of additional user fees
• To convert an IND into an NDA

Correct Answer: To delay IND effective date until additional information is provided to protect human subjects

Q3. A 505(b)(1) NDA is best described as which of the following?

• An application that relies entirely on FDA’s previous findings of safety and effectiveness
• A full NDA that relies solely on data developed by the applicant
• An abbreviated pathway for generics requiring bioequivalence only
• A permission to market a drug without any clinical data

Correct Answer: A full NDA that relies solely on data developed by the applicant

Q4. Which scenario is an appropriate use of a 505(b)(2) NDA?

• Filing for a generic copy of an unchanged reference listed drug with bioequivalence studies
• Seeking approval for a new dosage form that relies partly on published literature for safety data
• Submitting a pure chemical synthesis patent application
• Requesting an orphan designation for a biologic

Correct Answer: Seeking approval for a new dosage form that relies partly on published literature for safety data

Q5. Which exclusivity is typically granted for a new chemical entity under U.S. law?

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

Correct Answer: 5 years

Q6. Under an IND, serious and unexpected adverse events must be reported to FDA within what timeframe?

• 24 hours
• 7 days
• 15 calendar days for serious unexpected events; 7 days for life‑threatening
• 30 days

Correct Answer: 15 calendar days for serious unexpected events; 7 days for life‑threatening

Q7. Which meeting type with the FDA is convened urgently to address stalled programs or major safety issues?

• Type C meeting
• Type B meeting
• Type A meeting
• Pre-IND meeting

Correct Answer: Type A meeting

Q8. Which statement correctly distinguishes 505(b)(2) from ANDA?

• 505(b)(2) cannot reference any published literature; ANDA can
• ANDA relies on a listed drug’s safety and effectiveness findings and demonstrates bioequivalence; 505(b)(2) may rely partly on literature or FDA findings and can propose changes
• 505(b)(2) is only for biologics; ANDA is for small molecules
• ANDA allows patent certifications; 505(b)(2) does not

Correct Answer: ANDA relies on a listed drug’s safety and effectiveness findings and demonstrates bioequivalence; 505(b)(2) may rely partly on literature or FDA findings and can propose changes

Q9. In a 505(b)(2) application, a “bridging study” is used for what purpose?

• To replace all clinical safety data with animal data
• To connect literature or reference data to the applicant’s product, demonstrating comparability or addressing gaps
• To accomplish chemistry, manufacturing and controls validation only
• To extend patent protection automatically

Correct Answer: To connect literature or reference data to the applicant’s product, demonstrating comparability or addressing gaps

Q10. Which document contains the FDA’s list of approved drug products and therapeutic equivalence evaluations (Orange Book)?

• Code of Federal Regulations (CFR) Part 312
• Guidance for Industry
• Approved Drug Products with Therapeutic Equivalence Evaluations
• Yellow Book

Correct Answer: Approved Drug Products with Therapeutic Equivalence Evaluations

Q11. Which patent certification is associated with a Paragraph IV notice in an NDA or ANDA context?

• Certification that no relevant patents exist
• Certification that listed patents are invalid or will not be infringed by the new product
• Certification of clinical trial results
• Certification of manufacturing site compliance

Correct Answer: Certification that listed patents are invalid or will not be infringed by the new product

Q12. What is the role of an Investigator IND?

• To allow a sponsor to market a drug without controlled studies
• To permit an individual investigator to initiate and conduct clinical research and serve as sponsor if not part of a larger sponsor organization
• To approve a drug for pediatric use automatically
• To replace an NDA submission

Correct Answer: To permit an individual investigator to initiate and conduct clinical research and serve as sponsor if not part of a larger sponsor organization

Q13. Which of the following is a common reason the FDA might refuse to file an NDA?

• Applicant provided all required forms
• Application is incomplete or not in the required format
• Applicant paid all fees
• All preclinical studies are included

Correct Answer: Application is incomplete or not in the required format

Q14. REMS (Risk Evaluation and Mitigation Strategies) are required by FDA primarily to:

• Reduce manufacturing costs
• Ensure safe use of drugs with serious safety concerns while preserving access
• Extend market exclusivity
• Replace clinical trials

Correct Answer: Ensure safe use of drugs with serious safety concerns while preserving access

Q15. Which regulatory filing is most appropriate when seeking approval for a new active ingredient?

• ANDA
• 505(b)(2) NDA
• 505(b)(1) NDA
• Abbreviated biologics license application

Correct Answer: 505(b)(1) NDA

Q16. What is the typical exclusivity period granted for new clinical investigations that lead to approval of a new use for a previously approved drug?

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

Correct Answer: 3 years

Q17. Which section of an IND/NDA addresses stability, specifications, and manufacturing controls?

• Nonclinical pharmacology/toxicology
• Clinical study reports
• Chemistry, Manufacturing, and Controls (CMC)
• Labeling

Correct Answer: Chemistry, Manufacturing, and Controls (CMC)

Q18. Which of the following is TRUE about a 505(b)(2) applicant relying on published literature for safety information?

• The applicant must still demonstrate adequate CMC and may need additional clinical data to address differences
• No additional data or bridging is ever required
• FDA automatically grants 10 years exclusivity
• Applicant cannot change dosage form or route of administration

Correct Answer: The applicant must still demonstrate adequate CMC and may need additional clinical data to address differences

Q19. Which document must sponsors submit to FDA to request pediatric studies or obtain a pediatric waiver/deferral?

• Investigational New Drug application (IND) only
• Pediatric Study Plan (PSP)
• Biologics License Application (BLA)
• Drug Master File (DMF)

Correct Answer: Pediatric Study Plan (PSP)

Q20. If an applicant wants to rely on proprietary manufacturing information held by a third party, what filing mechanism can be used to allow FDA review without disclosing the proprietary details directly?

• Type B meeting
• Drug Master File (DMF)
• ANDA
• Investigational Device Exemption (IDE)

Correct Answer: Drug Master File (DMF)

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