CRAP CRAP Post-Market Surveillance & Vigilance 3 — Questions and Answers
Question 1: How does the Sentinel Initiative complement traditional passive surveillance systems like FAERS?
- It replaces spontaneous adverse event reporting entirely
- It conducts active surveillance by querying distributed electronic health records (Correct answer)
- It manages the FAERS database and adjudicates individual case reports
- It oversees post-approval clinical trials for all approved drugs
Correct answer: It conducts active surveillance by querying distributed electronic health records
Sentinel complements FAERS by actively querying distributed electronic health data networks to detect safety signals rather than relying solely on voluntary spontaneous reports.
Question 2: Which of the following best describes a corrective action within a CAPA (Corrective and Preventive Action) system?
- Documenting a procedure that was already performed correctly
- Investigating a root cause of nonconformance and implementing fixes to prevent recurrence (Correct answer)
- Performing scheduled routine quality audits on manufacturing processes
- Training new employees on standard operating procedures as part of onboarding
Correct answer: Investigating a root cause of nonconformance and implementing fixes to prevent recurrence
A corrective action addresses an identified nonconformance by determining its root cause and implementing process changes to prevent the problem from recurring.
Question 3: Under 21 CFR Part 7, how is a Class I recall defined?
- A situation where use of the product may cause temporary adverse health consequences
- A situation where use of the product is not likely to cause adverse health consequences
- A situation where use or exposure to the product will cause serious adverse health consequences or death (Correct answer)
- A voluntary market withdrawal initiated for minor defects
Correct answer: A situation where use or exposure to the product will cause serious adverse health consequences or death
A Class I recall is the most serious type, involving products where use or exposure is reasonably likely to cause serious adverse health consequences or death.
Question 4: What is a 'field safety corrective action' (FSCA) in the context of medical devices?
- An action taken in response to receiving an FDA warning letter
- Any action to reduce a risk of death or serious injury associated with an already-distributed device (Correct answer)
- A corrective action performed at the manufacturing facility before distribution
- An action required during pre-market device testing and validation
Correct answer: Any action to reduce a risk of death or serious injury associated with an already-distributed device
An FSCA is any action taken by a manufacturer or distributor to reduce the risk of death or serious health deterioration associated with a device already placed on the market.
Question 5: What must a Periodic Adverse Drug Experience Report (PADER) include for an NDA holder?
- Financial disclosures from clinical investigators involved in trials
- A summary of all adverse drug experiences received during the reporting period (Correct answer)
- Manufacturing process validation data collected post-approval
- Marketing authorization renewal documentation and labeling history
Correct answer: A summary of all adverse drug experiences received during the reporting period
PADERs require NDA holders to submit quarterly and annual summaries of all adverse drug experiences received during the reporting period, including domestic and foreign reports.
Question 6: What is the purpose of FDA's Expanded Access (compassionate use) program?
- It allows FDA to expand marketing authorization for post-approval drugs to new indications
- It provides patients with serious conditions access to investigational products outside clinical trials (Correct answer)
- It enables manufacturers to market unapproved drugs after completing post-market studies
- It expands FDA's authority to conduct unannounced post-market surveillance inspections
Correct answer: It provides patients with serious conditions access to investigational products outside clinical trials
The Expanded Access program allows patients with serious or life-threatening conditions to access investigational drugs or devices when no comparable alternatives exist and enrollment in a clinical trial is not feasible.
CRAP CRAP Post-Market Surveillance & Vigilance 3
How does the Sentinel Initiative complement traditional passive surveillance systems like FAERS?