FDA MedWatch & safety reporting MCQs With Answer

Introduction

FDA MedWatch & Safety Reporting MCQs With Answer is a focused collection of multiple-choice questions designed for M.Pharm students studying Clinical Research & Regulatory Requirements. This set emphasizes MedWatch operations, reporting forms, timelines, responsible parties, and how adverse event data are used by the FDA to protect public health. Questions range from basic definitions to regulatory nuances such as expedited IND reporting, manufacturer obligations, FAERS data use, and the difference between MedWatch and vaccine reporting systems. Practicing these MCQs will strengthen students’ understanding of post-marketing surveillance, regulatory timelines and the practical skills needed for pharmacovigilance and regulatory submissions.

Q1. What is FDA MedWatch primarily designed to do?

• Collect voluntary and mandatory reports of adverse events and product problems for FDA-regulated products
• Approve new drug applications and manufacture drugs
• Dispense medications to patients in emergency settings
• Monitor clinical trial subject enrollment rates

Correct Answer: Collect voluntary and mandatory reports of adverse events and product problems for FDA-regulated products

Q2. Which FDA form is intended for mandatory reporting by manufacturers and user facilities?

• FDA Form 3500A
• FDA Form 3500
• FDA Form 3500B
• FDA Form 1572

Correct Answer: FDA Form 3500A

Q3. Which form is a consumer-friendly voluntary MedWatch form specifically tailored for patients and consumers?

• FDA Form 3500B
• FDA Form 3500A
• FDA Form 3500
• FDA Form 483

Correct Answer: FDA Form 3500B

Q4. FAERS, which receives MedWatch reports, stands for which of the following?

• FDA Adverse Event Reporting System
• Federal Adverse Event Review Service
• Food and Drug Event Reporting System
• Faster Adverse Evaluation and Response System

Correct Answer: FDA Adverse Event Reporting System

Q5. Which types of products does MedWatch collect reports for?

• Drugs, biologics, medical devices and dietary supplements
• Only prescription drugs
• Only medical devices and equipment
• Food ingredients only

Correct Answer: Drugs, biologics, medical devices and dietary supplements

Q6. What reporting timeline applies to marketed drugs for a sponsor to submit a serious and unexpected adverse experience to the FDA?

• Within 15 calendar days
• Within 2 business days
• Within 60 days
• Within 72 hours

Correct Answer: Within 15 calendar days

Q7. Under an IND, when must a sponsor report an unexpected fatal or life‑threatening suspected adverse reaction to the FDA?

• Within 7 calendar days
• Within 30 calendar days
• Within 15 calendar days
• Only at the end of the study

Correct Answer: Within 7 calendar days

Q8. Which of the following is a primary use of MedWatch/FAERS data by the FDA?

• Signal detection and safety surveillance to identify new risks
• Setting drug prices for market entry
• Determining patent protection periods
• Conducting efficacy trials for new indications

Correct Answer: Signal detection and safety surveillance to identify new risks

Q9. Who is required to report adverse events to FDA using Form 3500A?

• Manufacturers, packers and distributors (mandatory reporters)
• Only consumers (voluntary)
• Clinical investigators for all expected events
• Only pharmacists during dispensing

Correct Answer: Manufacturers, packers and distributors (mandatory reporters)

Q10. Which reporting route is NOT supported by MedWatch?

• Telepathic notification
• Online electronic submission via MedWatch website
• Mail or fax of Form FDA 3500/3500A/3500B
• Telephone reporting to FDA MedWatch Safety Information Line

Correct Answer: Telepathic notification

Q11. Which of the following best defines a “serious” adverse event according to FDA regulatory reporting?

• Results in death, life‑threatening experience, hospitalization, disability, congenital anomaly, or other medically important condition
• Any mild transient headache or nausea
• Only events that require surgery
• Events that occur in healthy volunteers only

Correct Answer: Results in death, life‑threatening experience, hospitalization, disability, congenital anomaly, or other medically important condition

Q12. Which system should be used for reporting suspected adverse events following immunization?

• VAERS (Vaccine Adverse Event Reporting System)
• MedWatch only
• FAERS directly by consumers
• REMS mandatory hotline

Correct Answer: VAERS (Vaccine Adverse Event Reporting System)

Q13. Which fields are essential in a MedWatch report to make it actionable?

• Patient details (age/sex), suspect product, description of adverse event, reporter contact
• Only the manufacturer name
• Only the patient’s full medical history without event details
• Only the batch number of the product

Correct Answer: Patient details (age/sex), suspect product, description of adverse event, reporter contact

Q14. What is the role of a Risk Evaluation and Mitigation Strategy (REMS)?

• Mitigate specific serious risks associated with a drug while preserving access to use
• Determine drug patent expiry dates
• Set wholesale prices for high-risk drugs
• Authorize new clinical trials without IRB review

Correct Answer: Mitigate specific serious risks associated with a drug while preserving access to use

Q15. Which statement about MedWatch voluntary reporting is correct?

• Health care professionals and consumers can voluntarily report adverse events to FDA
• Only manufacturers may submit any reports to MedWatch
• Voluntary reports are never used in safety signal detection
• Voluntary reporting requires a signed physician affidavit

Correct Answer: Health care professionals and consumers can voluntarily report adverse events to FDA

Q16. How does the FDA typically use case reports submitted through MedWatch in pharmacovigilance?

• They are aggregated, analyzed for patterns, and may trigger follow-up, labeling changes, or further studies
• They are immediately used to withdraw all similar drugs from market
• They are forwarded to state authorities for pricing decisions
• They are filed but never reviewed

Correct Answer: They are aggregated, analyzed for patterns, and may trigger follow-up, labeling changes, or further studies

Q17. Which of the following best describes an “unexpected” adverse event?

• An event not listed in the current investigator brochure or product labeling as to nature, severity, or specificity
• Any event occurring in over 50% of patients
• An event that is common and listed in the product label
• Only events that occur during the first dose

Correct Answer: An event not listed in the current investigator brochure or product labeling as to nature, severity, or specificity

Q18. Which organization co-manages the Vaccine Adverse Event Reporting System (VAERS) alongside the FDA?

• Centers for Disease Control and Prevention (CDC)
• European Medicines Agency (EMA)
• World Health Organization (WHO)
• U.S. Department of Defense

Correct Answer: Centers for Disease Control and Prevention (CDC)

Q19. If a manufacturer receives a spontaneous serious adverse event report from a healthcare professional, what is the manufacturer’s primary obligation?

• Evaluate and submit a 15‑day expedited report to FDA if the event is unexpected and related
• Ignore it since spontaneous reports are not mandatory
• Only file it internally with no regulatory submission
• Send the report to international regulators only

Correct Answer: Evaluate and submit a 15‑day expedited report to FDA if the event is unexpected and related

Q20. Which public resource allows access to aggregated safety data derived from MedWatch/FAERS submissions?

• FDA FAERS Public Dashboard
• ClinicalTrials.gov only
• USP Compounding Database
• ChemSpider database

Correct Answer: FDA FAERS Public Dashboard

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