PVC Post-Marketing Surveillance 2

Question 1

Which regulatory mechanism allows the FDA to require a manufacturer to conduct post-marketing studies after drug approval?

Accepted Answer

Post-Market Requirement (PMR)

Answer

Post-Market Requirements (PMRs) are legally mandated studies the FDA can require of sponsors after approval, distinct from voluntary Post-Market Commitments.

Question 2

In a passive post-marketing surveillance system, data are primarily collected through:

Accepted Answer

Spontaneous adverse event reports submitted voluntarily

Answer

Passive surveillance relies on voluntary, spontaneous reporting of adverse events by healthcare professionals, patients, and manufacturers.

Question 3

The Weber effect in pharmacovigilance refers to:

Accepted Answer

A peak in adverse event reporting that occurs within the first 1–2 years after a drug's launch

Answer

The Weber effect describes the pattern where spontaneous adverse event reporting peaks 1–2 years after a drug is marketed, then declines as novelty fades.

Question 4

Which database is the FDA's primary tool for receiving and managing post-marketing safety reports in the United States?

Accepted Answer

FAERS (FDA Adverse Event Reporting System)

Answer

FAERS is the FDA's spontaneous reporting database that collects adverse event and medication error reports submitted by healthcare professionals, consumers, and manufacturers.

Question 5

A drug sponsor identifies a new safety signal in post-marketing data. What is the FIRST regulatory action typically required?

Accepted Answer

Evaluate the signal and report it to the FDA within required timeframes

Answer

Upon identifying a potential safety signal, the sponsor must evaluate it and report to the FDA according to prescribed expedited or periodic reporting timelines.

(PVC) Pharmacovigilance Certification Practice Test

(PVC) Pharmacovigilance Certification Practice Test

PVC Post-Marketing Surveillance 2