Abbreviated New Drug Application (ANDA) informational content MCQs With Answer

Abbreviated New Drug Application (ANDA) informational content MCQs With Answer

This quiz set is designed for M.Pharm students focusing on Product Development and Technology Transfer. It reviews regulatory, scientific and technical aspects of ANDA submissions, covering bioequivalence, reference listed drug (RLD) selection, Hatch-Waxman provisions, Paragraph certifications, Orange Book listings, formulation sameness, biowaivers based on the Biopharmaceutics Classification System (BCS), and post-approval changes. The questions emphasize practical application—study design, documentation (e.g., Form 356h, DMFs), therapeutic equivalence coding, exclusivity and patent issues—preparing students to evaluate ANDA strategies and regulatory expectations during generic drug development and tech transfer processes.

Q1. What is the primary purpose of an Abbreviated New Drug Application (ANDA)?

• To submit full clinical efficacy data for a new chemical entity
• To obtain approval for a generic drug by demonstrating pharmaceutical equivalence and bioequivalence to an RLD
• To request orphan drug designation for a specialty product
• To register an investigational new drug for clinical trials

Correct Answer: To obtain approval for a generic drug by demonstrating pharmaceutical equivalence and bioequivalence to an RLD

Q2. Under US regulations, which statutory section governs ANDA submissions?

• Section 505(b)(2)
• Section 505(j)
• Section 505(b)(1)
• Section 505(a)

Correct Answer: Section 505(j)

Q3. What is a Reference Listed Drug (RLD) in the context of an ANDA?

• The generic product proposed in the ANDA
• The innovator drug product to which bioequivalence and labeling are compared
• A drug used only for stability studies
• An inactive placebo used in bioequivalence trials

Correct Answer: The innovator drug product to which bioequivalence and labeling are compared

Q4. Which form is typically used to provide a complete application certification for an ANDA to the US FDA?

• Form FDA 356h
• Form FDA 1571
• Form FDA 483
• Form FDA 3456

Correct Answer: Form FDA 356h

Q5. What is the main scientific basis to waive in vivo bioequivalence studies under a BCS-based biowaiver?

• High permeability and high solubility (BCS Class I) with rapid dissolution for both test and RLD
• Low permeability and low solubility requiring formulation optimization
• Identical excipient composition between test and RLD
• Demonstration of therapeutic superiority over the RLD

Correct Answer: High permeability and high solubility (BCS Class I) with rapid dissolution for both test and RLD

Q6. Which Orange Book designation indicates that two products are therapeutically equivalent?

• TE (Therapeutic Equivalent)
• AB (Approved, Bioequivalent)
• BT (Biotherapeutic)
• NR (Not Rated)

Correct Answer: AB (Approved, Bioequivalent)

Q7. What is the significance of a Paragraph IV certification in an ANDA?

• It declares that the ANDA applicant will withdraw the application if sued
• It states that the patent listed for the RLD is invalid or will not be infringed by the generic
• It confirms the applicant’s reliance on an active DMF
• It requests a waiver for clinical trials

Correct Answer: It states that the patent listed for the RLD is invalid or will not be infringed by the generic

Q8. What period of exclusivity can a successful first-to-file Paragraph IV ANDA applicant receive?

• 6 months
• 180 days
• 5 years
• 1 year

Correct Answer: 180 days

Q9. In bioequivalence studies, which pharmacokinetic parameters are most commonly compared?

• Cmax and Tmax only
• AUC and Cmax
• Half-life and clearance only
• Volume of distribution and bioavailability fraction

Correct Answer: AUC and Cmax

Q10. Which dissolution comparison metric is often used to assess similarity between generic and RLD profiles?

• f1 (difference factor) and f2 (similarity factor)
• pH shift index
• HPLC peak purity index
• Relative bioavailability ratio

Correct Answer: f1 (difference factor) and f2 (similarity factor)

Q11. What role does a Drug Master File (DMF) play in an ANDA?

• It is a public dossier that describes the clinical trials for the ANDA
• It allows a supplier to provide confidential information (e.g., CEPs, manufacturing) to FDA without disclosing it to the applicant
• It replaces the need for stability data in the ANDA
• It is only required for biologic products

Correct Answer: It allows a supplier to provide confidential information (e.g., CEPs, manufacturing) to FDA without disclosing it to the applicant

Q12. Which of the following differences between a generic and the RLD is generally acceptable in an ANDA?

• Different route of administration
• Different active ingredient salt form without bridging studies
• Different strength with proportional formulation adjustments and supportive data
• Different indication of use

Correct Answer: Different strength with proportional formulation adjustments and supportive data

Q13. For modified-release oral products, why is demonstrating BE often more complex than for immediate-release forms?

• Because modified-release products never require in vivo testing
• Due to the complexity of release mechanisms, need for multiple dissolution conditions, and potential for in vivo-in vitro correlation (IVIVC)
• Because excipients are not regulated for modified-release forms
• Because bioavailability is always 100% for modified-release products

Correct Answer: Due to the complexity of release mechanisms, need for multiple dissolution conditions, and potential for in vivo-in vitro correlation (IVIVC)

Q14. What is a therapeutic equivalence code beginning with “AB” followed by a number (e.g., AB1) used to indicate?

• That the product is not interchangeable with other generics
• Specific product-by-product equivalence where multiple pharmaceutically equivalent products are bioequivalent to the same RLD
• That the product is a biosimilar
• That the product has unresolved quality issues

Correct Answer: Specific product-by-product equivalence where multiple pharmaceutically equivalent products are bioequivalent to the same RLD

Q15. Which regulatory requirement ensures that an ANDA applicant provides adequate manufacturing process and controls?

• Submission of Module 3 (Quality) including CMC, process validation, and batch records
• Only submission of preclinical toxicology reports
• Provision of investigator brochures
• Submission of patent claims

Correct Answer: Submission of Module 3 (Quality) including CMC, process validation, and batch records

Q16. When considering excipient differences between a generic and RLD, which statement is true?

• Any excipient change is allowed without justification
• Excipients must be qualitatively the same and quantitatively the same or justified with data if different
• Excipients cannot affect regulatory review of an ANDA
• Only colorants are scrutinized; other excipients are irrelevant

Correct Answer: Excipients must be qualitatively the same and quantitatively the same or justified with data if different

Q17. Which action by an ANDA applicant can trigger a 30-month stay of FDA approval due to patent litigation?

• Filing a Paragraph IV certification and receiving a patent infringement suit from the RLD patent owner
• Submitting a BCS biowaiver request
• Changing the container closure system post-approval
• Requesting an advisory committee meeting

Correct Answer: Filing a Paragraph IV certification and receiving a patent infringement suit from the RLD patent owner

Q18. What is the typical statistical bioequivalence acceptance range for AUC and Cmax in a crossover study?

• 50–150%
• 80–125% for the 90% confidence interval of the geometric mean ratio
• 90–110% with 95% confidence interval
• 0–200% with no confidence interval required

Correct Answer: 80–125% for the 90% confidence interval of the geometric mean ratio

Q19. Which post-approval change in an approved generic product typically requires prior approval supplement rather than a CBE-0 or CBE-30?

• Minor editorial labeling change
• Change in the manufacturing site that could affect product quality without adequate bridging data
• Change in colorant shade when clinically irrelevant
• Change in marketing trade name

Correct Answer: Change in the manufacturing site that could affect product quality without adequate bridging data

Q20. Which test or documentation is critical to demonstrate sameness of semi-solid topical generics to the RLD?

• Only disintegration time
• Comparative characterization of rheology, in vitro release (IVRT), microstructure, and where appropriate, bioequivalence studies
• Only color matching
• Only in vitro antimicrobial preservative efficacy

Correct Answer: Comparative characterization of rheology, in vitro release (IVRT), microstructure, and where appropriate, bioequivalence studies

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