ANDA 505(j) requirements MCQs With Answer

Introduction: ANDA 505(j) requirements MCQs With Answer is a focused collection of multiple-choice questions designed specifically for M.Pharm students preparing for exams in Clinical Research & Regulatory Requirements. This set explains the core principles of the Abbreviated New Drug Application (ANDA) pathway under section 505(j) of the US Federal Food, Drug, and Cosmetic Act. Questions cover reference listed drug selection, bioequivalence standards, patent certifications, exclusivity issues, labeling, and regulatory submissions like suitability petitions and DMFs. The MCQs emphasize practical regulatory interpretation, decision-making on biowaivers, and post-approval obligations to help students build strong conceptual knowledge and exam-ready confidence.

Q1. What is the primary purpose of an ANDA submitted under 505(j)?

• To request approval for a new chemical entity with novel clinical data
• To seek approval for a generic drug demonstrating bioequivalence to a reference listed drug
• To obtain orphan drug designation for rare disease treatment
• To file for a new indication for an already marketed brand drug

Correct Answer: To seek approval for a generic drug demonstrating bioequivalence to a reference listed drug

Q2. Under 505(j), which document contains the list of patent and exclusivity information for approved drugs used by ANDA applicants?

• The Purple Book
• The Orange Book
• The Green Book
• The Blue Book

Correct Answer: The Orange Book

Q3. A Paragraph IV certification in an ANDA indicates which of the following?

• The applicant agrees to abide by all patents listed for the reference listed drug
• The applicant claims the patent is invalid or will not be infringed by the generic product
• The applicant has obtained a license from the patent holder
• The applicant is seeking an extension of brand exclusivity

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

Q4. Which of the following is a key technical requirement often necessary in an ANDA to demonstrate pharmaceutical equivalence?

• Phase III clinical endpoint studies
• Bioequivalence studies showing similar rate and extent of absorption
• Large-scale epidemiological safety studies
• Pediatric clinical trials for new indication

Correct Answer: Bioequivalence studies showing similar rate and extent of absorption

Q5. Which type of exclusivity prevents approval of an ANDA for a period of five years after the brand approval?

• Patent term extension
• New Chemical Entity (NCE) exclusivity
• Orphan drug exclusivity
• Data exclusivity for clinical trial data beyond 10 years

Correct Answer: New Chemical Entity (NCE) exclusivity

Q6. When can an ANDA applicant file a 505(j) suitability petition?

• To replace the reference listed drug with a different, non-therapeutically equivalent active moiety
• To request permission to use a different strength, dosage form, or a different listed drug than the RLD when certain conditions are met
• To obtain pediatric exclusivity for their generic product
• To appeal an FDA complete response letter

Correct Answer: To request permission to use a different strength, dosage form, or a different listed drug than the RLD when certain conditions are met

Q7. Which of the following is true about bioequivalence acceptance criteria typically used by FDA for AUC and Cmax?

• The 90% confidence interval for the geometric mean ratios must lie within 70–143%
• The 90% confidence interval for the geometric mean ratios must lie within 80–125%
• The 95% confidence interval for arithmetic means must lie within 85–115%
• Any statistical interval is acceptable if point estimates are similar

Correct Answer: The 90% confidence interval for the geometric mean ratios must lie within 80–125%

Q8. Which DEA/REM statement is required in an ANDA for a product that is a controlled substance?

• A full REMS submission identical to the RLD REMS
• A statement about scheduling and how the generic will comply with controlled-substance requirements
• A declaration that control scheduling is not applicable to generics
• None; the FDA does not require controlled-substance information in ANDAs

Correct Answer: A statement about scheduling and how the generic will comply with controlled-substance requirements

Q9. Which submission element allows an ANDA to rely on confidential technical information held by the innovator, referenced without disclosing it—often via an FDA-held dossier?

• Active pharmaceutical ingredient patent certification
• Drug Master File (DMF) reference
• Clinical study waiver
• Abbreviated labeling appendix

Correct Answer: Drug Master File (DMF) reference

Q10. What is the consequence of filing a Paragraph IV certification in an ANDA?

• Immediate approval of the ANDA regardless of patents
• Automatic stay of 30 months if the patent holder sues for patent infringement within 45 days
• Requirement to submit full clinical trials for the generic product
• Loss of any potential 180-day exclusivity for the applicant

Correct Answer: Automatic stay of 30 months if the patent holder sues for patent infringement within 45 days

Q11. Which ANDA pathway permits reliance on public literature and FDA findings for safety and efficacy, differing from 505(j)?

• 505(b)(2) application
• New Drug Application (NDA) 505(c)
• Orphan drug application
• Abbreviated biological license application (aBLA)

Correct Answer: 505(b)(2) application

Q12. Therapeutic equivalence codes in the Orange Book that indicate a generic product is substitutable at the pharmacy level typically include which code?

• AA for injectable biologics
• AB indicating bioequivalent and pharmaceutically equivalent
• CC indicating clinical superiority
• ZZ indicating restricted distribution

Correct Answer: AB indicating bioequivalent and pharmaceutically equivalent

Q13. For immediate-release oral solid dosage forms, when might a biowaiver based on in vitro dissolution data be acceptable for an ANDA?

• When the generic has a different active moiety than the RLD
• When the drug is BCS Class I or certain Class III drugs meeting strict dissolution and excipient criteria
• When the generic product demonstrates a novel release mechanism
• For all controlled substances regardless of permeability

Correct Answer: When the drug is BCS Class I or certain Class III drugs meeting strict dissolution and excipient criteria

Q14. What is the role of the Reference Listed Drug (RLD) in an ANDA submission?

• It is the generic product used to demonstrate interchangeability
• It is the originally approved drug to which the generic applicant compares quality, performance, and labeling
• It is an investigational new drug used for bridging studies
• It is the innovator’s manufacturing process dossier

Correct Answer: It is the originally approved drug to which the generic applicant compares quality, performance, and labeling

Q15. Which regulatory document must ANDA applicants submit to demonstrate that analytical methods and manufacturing controls are adequate?

• Clinical study protocol
• Chemistry, Manufacturing, and Controls (CMC) section
• Risk Evaluation and Mitigation Strategy (REMS)
• Environmental assessment only

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

Q16. How long is the 180-day exclusivity period reserved for a first approved ANDA applicant who successfully challenges a patent (i.e., first-filer)?

• 180 days starting from the NDA approval date of the RLD
• 180 days from the date the first-filer receives tentative approval or actual approval as defined by FDA policy
• 180 days from filing the ANDA regardless of approval status
• 180 days only if the applicant receives a pediatric exclusivity extension

Correct Answer: 180 days from the date the first-filer receives tentative approval or actual approval as defined by FDA policy

Q17. If an ANDA applicant wants to reference a DMF held by another company, what is required?

• No permission is needed; all DMFs are public
• The DMF holder must provide a letter of authorization to the FDA for the applicant to reference it
• The applicant must submit a new duplicate DMF
• The applicant must own the DMF or acquire the underlying patent rights

Correct Answer: The DMF holder must provide a letter of authorization to the FDA for the applicant to reference it

Q18. Which of the following changes post-approval for a generic product may require a Prior Approval Supplement rather than being handled by a Changes Being Effected (CBE) submission?

• Minor change in supplier of a non-critical excipient
• Change in the approved bioequivalence study design affecting safety
• Typographical correction in labeling
• Change in batch size within validated range

Correct Answer: Change in the approved bioequivalence study design affecting safety

Q19. What is the primary distinction between a 505(j) ANDA and a 505(b)(2) application regarding reliance on prior findings?

• 505(j) relies on data generated by the applicant, while 505(b)(2) relies exclusively on public literature
• 505(j) fully relies on the FDA’s previous findings of safety and effectiveness for the RLD, while 505(b)(2) relies in part on literature or FDA findings but may require additional clinical data
• 505(j) is used only for biologics, 505(b)(2) for small molecules
• There is no regulatory difference in reliance between 505(j) and 505(b)(2)

Correct Answer: 505(j) fully relies on the FDA’s previous findings of safety and effectiveness for the RLD, while 505(b)(2) relies in part on literature or FDA findings but may require additional clinical data

Q20. If an ANDA applicant fails to list a patent in the Orange Book that later should have been listed, what consequence can occur?

• The ANDA is automatically approved with no penalties
• The applicant may be subject to patent infringement claims and potential advisory actions; late listing can complicate patent litigation timing
• The FDA will delist the RLD from the Orange Book
• The applicant will receive automatic 5-year exclusivity

Correct Answer: The applicant may be subject to patent infringement claims and potential advisory actions; late listing can complicate patent litigation timing

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