Organization structure of US FDA and application types MCQs With Answer

Understanding the organization structure of the US FDA and application types is essential for B.Pharm students focusing on regulatory affairs and drug development. This concise guide explains FDA centers (CDER, CBER, CDRH, CVM), key offices, regulatory pathways and common application types such as IND, NDA, ANDA, BLA, 505(b)(2), 510(k) and PMA. It also covers review designations—priority review, accelerated approval, orphan drug status—plus post-marketing obligations like REMS and pharmacovigilance. Knowledge of FDA structure, submission requirements, good manufacturing practices (cGMP), and regulatory timelines prepares pharmacy graduates for roles in quality assurance, regulatory affairs, clinical research and drug safety. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. Which FDA center is primarily responsible for regulation of human drugs?

• Center for Biologics Evaluation and Research (CBER)
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Center for Veterinary Medicine (CVM)

Correct Answer: Center for Drug Evaluation and Research (CDER)

Q2. What does BLA stand for in FDA application terminology?

• Biologics License Application
• Bulk License Application
• Basic Labeling Approval
• Biological Label Assessment

Correct Answer: Biologics License Application

Q3. Which submission allows clinical trials to begin in humans?

• New Drug Application (NDA)
• Investigational New Drug application (IND)
• Abbreviated New Drug Application (ANDA)
• Pre-Market Approval (PMA)

Correct Answer: Investigational New Drug application (IND)

Q4. ANDA is primarily submitted for which purpose?

• Approval of a new biological product
• Approval of a generic small-molecule drug
• Approval of a new medical device
• Approval of an over-the-counter monograph

Correct Answer: Approval of a generic small-molecule drug

Q5. Which FDA application type is used for entirely new chemical entity seeking marketing approval?

• Abbreviated New Drug Application (ANDA)
• New Drug Application (NDA)
• 510(k) Premarket Notification
• De novo request

Correct Answer: New Drug Application (NDA)

Q6. Which center reviews vaccines and blood products?

• CDER
• CBER
• CDRH
• CVM

Correct Answer: CBER

Q7. The 510(k) pathway is associated with which product category?

• Human drugs
• Biologics
• Medical devices
• Veterinary drugs

Correct Answer: Medical devices

Q8. Which application type is required for high-risk medical devices?

• 505(b)(2)
• Abbreviated New Drug Application (ANDA)
• Pre-Market Approval (PMA)
• Investigational New Drug application (IND)

Correct Answer: Pre-Market Approval (PMA)

Q9. What is a 505(b)(2) application?

• An NDA relying entirely on new clinical data
• A hybrid NDA that can rely on published literature and/or third-party data
• An application for device clearance
• A veterinary medicine approval

Correct Answer: A hybrid NDA that can rely on published literature and/or third-party data

Q10. Which FDA office coordinates inspections and compliance for manufacturing?

• Office of New Drugs
• Office of Compliance
• Office of Device Evaluation
• Office of Biostatistics

Correct Answer: Office of Compliance

Q11. Which program allows faster review for drugs addressing unmet medical needs with preliminary clinical evidence?

• Priority Review
• Breakthrough Therapy designation
• Standard Review
• Abbreviated Review

Correct Answer: Breakthrough Therapy designation

Q12. What is the main purpose of REMS (Risk Evaluation and Mitigation Strategies)?

• To accelerate drug approval timelines
• To manage known or potential serious risks of a drug after approval
• To replace clinical trials
• To approve generics without bioequivalence

Correct Answer: To manage known or potential serious risks of a drug after approval

Q13. Which FDA database lists therapeutic equivalence of approved generic drugs?

• ClinicalTrials.gov
• Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)
• MedWatch
• Biologics License Directory

Correct Answer: Orange Book (Approved Drug Products with Therapeutic Equivalence Evaluations)

Q14. Which designation gives a shorter FDA review goal date, typically six months?

• Fast Track
• Priority Review
• Standard Review
• Orphan Drug designation

Correct Answer: Priority Review

Q15. What does PDUFA relate to?

• Drug safety monitoring after approval
• Prescription Drug User Fee Act allowing FDA to collect fees to expedite reviews
• Device classification rules
• Clinical trial registration requirements

Correct Answer: Prescription Drug User Fee Act allowing FDA to collect fees to expedite reviews

Q16. Which process establishes bioequivalence for generic drug approvals?

• Nonclinical toxicology studies
• Bioavailability and bioequivalence studies
• Device bench testing
• Labeling negotiations only

Correct Answer: Bioavailability and bioequivalence studies

Q17. Which FDA pathway may allow approval based on surrogate endpoints?

• Accelerated Approval
• Standard Approval
• 510(k) Clearance
• ANDA pathway

Correct Answer: Accelerated Approval

Q18. The FDA office primarily responsible for veterinary drug regulation is:

• CBER
• CVM
• CDRH
• CDER

Correct Answer: CVM

Q19. De novo classification request is used for:

• Generic drug approval
• Devices of low to moderate risk without a predicate device
• Biologics licensing
• IND amendments

Correct Answer: Devices of low to moderate risk without a predicate device

Q20. Which FDA system is used by healthcare professionals to report adverse events?

• Orange Book
• MedWatch
• ClinicalTrials.gov
• Labeling Portal

Correct Answer: MedWatch

Q21. Which requirement is a key element of cGMP?

• Conducting only animal studies
• Maintaining quality systems, documentation and validated processes
• Skipping facility inspections
• Automated labeling without oversight

Correct Answer: Maintaining quality systems, documentation and validated processes

Q22. What does a Priority Review designation affect?

• The clinical trial design
• The FDA review time goal for an application
• The requirement for manufacturing inspections
• The legality of marketing materials

Correct Answer: The FDA review time goal for an application

Q23. Which is true about an EUA (Emergency Use Authorization)?

• It is a full marketing approval
• It permits temporary use of unapproved medical products in emergency situations
• It replaces NDAs permanently
• It is only for veterinary products

Correct Answer: It permits temporary use of unapproved medical products in emergency situations

Q24. Who registers drug establishments and lists drug products with FDA?

• Drug sponsor or manufacturer
• Individual pharmacists
• Clinical investigators only
• Third-party vendors exclusively

Correct Answer: Drug sponsor or manufacturer

Q25. Which submission is reviewed by CDER for safety and efficacy of a marketed drug?

• Investigational New Drug application (IND)
• New Drug Application (NDA)
• 510(k)
• De novo request

Correct Answer: New Drug Application (NDA)

Q26. Orphan Drug designation primarily provides what benefit?

• Shorter clinical trials
• Incentives like market exclusivity and fee waivers for rare disease drugs
• Automatic approval without data
• Device classification changes

Correct Answer: Incentives like market exclusivity and fee waivers for rare disease drugs

Q27. Which FDA office issues guidance documents and policy on drugs?

• Office of Regulatory Affairs (ORA)
• Office of New Drugs (OND) within CDER
• Center for Devices and Radiological Health (CDRH)
• Center for Veterinary Medicine (CVM)

Correct Answer: Office of New Drugs (OND) within CDER

Q28. A PMA requires what level of evidence compared to a 510(k)?

• Less evidence than a 510(k)
• Similar evidence as ANDA submissions
• Valid scientific evidence of safety and effectiveness, generally more rigorous than 510(k)
• No clinical data

Correct Answer: Valid scientific evidence of safety and effectiveness, generally more rigorous than 510(k)

Q29. Post-marketing pharmacovigilance typically includes:

• Preclinical toxicology only
• Ongoing safety monitoring, adverse event reporting and periodic safety updates
• Device labeling approvals only
• Elimination of REMS obligations

Correct Answer: Ongoing safety monitoring, adverse event reporting and periodic safety updates

Q30. Which FDA office leads inspections of manufacturing facilities and enforces compliance?

• Office of Medical Products and Tobacco
• Office of Regulatory Affairs (ORA)
• Office of Biostatistics
• Office of Clinical Policy

Correct Answer: Office of Regulatory Affairs (ORA)

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