Supplemental New Drug Application (SNDA) MCQs With Answer

Introduction

Supplemental New Drug Application (SNDA) MCQs With Answer is a focused study resource designed for M.Pharm students preparing for exams in Product Development and Technology Transfer. This blog provides clear, concise multiple-choice questions covering regulatory rationale, types of supplements, documentation requirements, classification of post-approval changes, comparability protocols, and study/data expectations for SNDA submissions. The questions emphasize practical decision-making about when to use CBE versus Prior Approval Supplement, stability and bioequivalence requirements, labeling and REMS changes, and interactions with DMFs and user-fee obligations. Use these MCQs to test knowledge depth, identify gaps, and strengthen understanding of post-approval change management under regulatory frameworks.

Q1. What is the primary purpose of a Supplemental New Drug Application (SNDA)?

• To request initial marketing authorization for a new drug
• To propose and obtain approval for changes to an already approved New Drug Application
• To apply for over-the-counter (OTC) conversion without any safety data
• To submit periodic annual reports only

Correct Answer: To propose and obtain approval for changes to an already approved New Drug Application

Q2. Which type of supplement allows the manufacturer to distribute the product immediately, while the FDA reviews the change?

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

Correct Answer: Changes Being Effected (CBE) supplement

Q3. A CBE-30 submission specifically refers to:

• An immediate distribution without notification
• Changes implemented without delay and no FDA review
• A CBE where the sponsor may distribute after 30 days unless FDA acts
• A Prior Approval Supplement that takes exactly 30 days to approve

Correct Answer: A CBE where the sponsor may distribute after 30 days unless FDA acts

Q4. Which type of change normally requires a Prior Approval Supplement (PAS)?

• Minor labeling typo correction
• Change in manufacturing site that could affect product quality
• Change in primary packaging color with no quality impact
• Routine annual stability report

Correct Answer: Change in manufacturing site that could affect product quality

Q5. Which document is commonly used by applicants to provide administrative information when submitting an SNDA to FDA?

• IND Form 1571
• Form FDA 356h
• Abbreviated New Drug Application form
• Drug Master File cover letter only

Correct Answer: Form FDA 356h

Q6. When is a bioequivalence or bridging study most likely required for an SNDA?

• For a label wording clarification that does not change dosing
• For formulation changes that may alter absorption or bioavailability
• For a change in marketing team contact information
• For annual report of adverse events

Correct Answer: For formulation changes that may alter absorption or bioavailability

Q7. What is a comparability protocol in the context of an SNDA?

• A protocol to compare two marketed drugs from different sponsors
• A pre-approved plan detailing how certain post-approval changes will be evaluated to ensure product quality
• A standard clinical trial protocol for new indications
• An internal manufacturing SOP that never gets submitted to FDA

Correct Answer: A pre-approved plan detailing how certain post-approval changes will be evaluated to ensure product quality

Q8. Which of the following changes can often be implemented using a CBE-0 (immediate CBE)?

• Major change in active moiety or therapeutic indication
• Change that adds a new contraindication
• Labeling change to strengthen a warning based on new safety data
• Introduction of a completely new formulation

Correct Answer: Labeling change to strengthen a warning based on new safety data

Q9. What regulatory consequence may follow if a sponsor implements a significant manufacturing change without required SNDA approval?

• Automatic exclusivity extension
• Potential enforcement action, including product seizure or injunction
• No consequence if stability data is later provided
• Immediate approval by default after one year

Correct Answer: Potential enforcement action, including product seizure or injunction

Q10. Which regulatory pathway would a sponsor use to change the approved indication of a drug?

• Submit an SNDA/Prior Approval Supplement to the approved NDA
• File an Abbreviated New Drug Application (ANDA)
• Only update the label in the annual report
• Submit a Drug Master File update

Correct Answer: Submit an SNDA/Prior Approval Supplement to the approved NDA

Q11. When referencing an independent Drug Master File (DMF) in an SNDA, what is required if the DMF owner changes critical API manufacturing steps?

• No notification is ever required
• The DMF holder must update the DMF and the NDA holder may need to submit an SNDA if the change affects quality
• The NDA sponsor must withdraw the application
• The change is automatically accepted without any data

Correct Answer: The DMF holder must update the DMF and the NDA holder may need to submit an SNDA if the change affects quality

Q12. Which of the following is NOT typically reviewed under an SNDA?

• Changes to the formulation affecting dissolution
• New adverse event reports unrelated to a manufacturing change
• Change in container closure system that impacts stability
• Change in manufacturing facility equipment that affects CQAs

Correct Answer: New adverse event reports unrelated to a manufacturing change

Q13. For a scale-up of batch size that might affect impurity profile, the sponsor should submit:

• An Annual Report only
• A Prior Approval Supplement with necessary validation and stability data
• A simple cover letter with no data
• No submission if in the same facility

Correct Answer: A Prior Approval Supplement with necessary validation and stability data

Q14. Which statement about user fees for supplemental applications is correct (US context)?

• All SNDA submissions are always exempt from user fees
• Most significant supplements may be subject to FDA user fees unless exempted
• User fees are only required for INDs, not supplements
• Fees are paid only after approval is granted

Correct Answer: Most significant supplements may be subject to FDA user fees unless exempted

Q15. A sponsor wants to add a new strength of an approved product with a different formulation; which regulatory action is most appropriate?

• File a new NDA as it is a new product
• Submit an SNDA/Prior Approval Supplement with bridging data
• Only change the label via annual report
• Update the DMF only

Correct Answer: Submit an SNDA/Prior Approval Supplement with bridging data

Q16. How are stability data ordinarily handled when proposing formulation or packaging changes in an SNDA?

• No stability data is ever required for post-approval changes
• Appropriate accelerated and long-term stability data must be included to demonstrate product quality over shelf life
• Only in-use stability is required
• Stability data can be submitted after marketing indefinitely

Correct Answer: Appropriate accelerated and long-term stability data must be included to demonstrate product quality over shelf life

Q17. Which change would most likely require clinical data or labeling changes assessed via an SNDA?

• Minor ink color change on secondary packaging
• Change in route of administration (e.g., oral to parenteral)
• Typographical correction in the package insert
• Change in distributor name only

Correct Answer: Change in route of administration (e.g., oral to parenteral)

Q18. What is the role of a stability-indicating assay validation when submitting an SNDA for formulation change?

• It is optional and never required
• It ensures the analytical method can detect relevant degradation products and supports stability conclusions
• It only matters for biologics and not small molecules
• It is relevant only for container closure changes

Correct Answer: It ensures the analytical method can detect relevant degradation products and supports stability conclusions

Q19. If a sponsor intends to add a Risk Evaluation and Mitigation Strategy (REMS) element, they must:

• Implement it immediately without FDA interaction
• Submit an SNDA proposing the REMS change and obtain FDA concurrence
• Only inform wholesalers with no regulatory filing
• File a DMF instead of an SNDA

Correct Answer: Submit an SNDA proposing the REMS change and obtain FDA concurrence

Q20. Which of the following best distinguishes an SNDA from an ANDA supplement?

• SNDA applies to approved NDAs (brand products) for post-approval changes; ANDA supplements are for approved generic products and their specific post-approval changes
• SNDA is only for OTC drugs while ANDA is for prescription drugs
• SNDA submissions never require any stability or comparative data
• There is no difference; they are interchangeable terms

Correct Answer: SNDA applies to approved NDAs (brand products) for post-approval changes; ANDA supplements are for approved generic products and their specific post-approval changes

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