Post-Marketing Surveillance Flashcards
7 cards from real PVC practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 7 Post-Marketing Surveillance flashcards as text
Which regulatory mechanism allows the FDA to require a manufacturer to conduct post-marketing studies after drug approval?
Answer: Post-Market Requirement (PMR)
Post-Market Requirements (PMRs) are legally mandated studies the FDA can require of sponsors after approval, distinct from voluntary Post-Market Commitments.
In a passive post-marketing surveillance system, data are primarily collected through:
Answer: Spontaneous adverse event reports submitted voluntarily
Passive surveillance relies on voluntary, spontaneous reporting of adverse events by healthcare professionals, patients, and manufacturers.
The Weber effect in pharmacovigilance refers to:
Answer: A peak in adverse event reporting that occurs within the first 1–2 years after a drug's launch
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.
Which database is the FDA's primary tool for receiving and managing post-marketing safety reports in the United States?
Answer: FAERS (FDA Adverse Event Reporting System)
FAERS is the FDA's spontaneous reporting database that collects adverse event and medication error reports submitted by healthcare professionals, consumers, and manufacturers.
A drug sponsor identifies a new safety signal in post-marketing data. What is the FIRST regulatory action typically required?
Answer: Evaluate the signal and report it to the FDA within required timeframes
Upon identifying a potential safety signal, the sponsor must evaluate it and report to the FDA according to prescribed expedited or periodic reporting timelines.
Prescription Event Monitoring (PEM), as used in the UK, is best described as:
Answer: An active surveillance method tracking all prescriptions for selected new drugs and collecting outcomes from GPs
PEM is an active, observational, cohort-based system that monitors prescriptions issued by GPs and follows up to collect patient outcome data.
Under 21 CFR Part 314.81, a US drug manufacturer is required to submit a Periodic Adverse Drug Experience Report (PADER) to the FDA at what minimum frequency for a product within its first three years post-approval?
Answer: Quarterly
For the first three years post-approval, PADERs must be submitted quarterly, after which annual submissions are required.