CRAP Post-Market Surveillance & Vigilance Flashcards
6 cards from real CRAP practice questions. Tap to flip, then mark Knew It or Still Learning — missed cards come back until you master them.
Read the first 6 CRAP Post-Market Surveillance & Vigilance flashcards as text
What is the primary purpose of FDA's MedWatch program?
Answer: To collect voluntary safety reports on adverse events from marketed products
MedWatch is FDA's voluntary reporting system that collects adverse event and safety information on marketed medical products from healthcare professionals and consumers.
Under 21 CFR Part 314.81, what is the required timeframe for an NDA holder to submit an expedited 15-day alert report?
Answer: 15 calendar days
NDA holders must submit expedited safety reports to FDA within 15 calendar days of receiving information about serious and unexpected adverse drug experiences.
Under FDA regulations, which outcome qualifies an adverse event as 'serious'?
Answer: Death, life-threatening condition, hospitalization, disability, or congenital anomaly
A serious adverse event is defined as one resulting in death, life-threatening conditions, inpatient hospitalization, significant disability, congenital anomaly, or requiring medical intervention to prevent permanent harm.
Which FDA database is used for post-market surveillance of adverse events for drugs and biologics?
Answer: FAERS (FDA Adverse Event Reporting System)
FAERS is FDA's pharmacovigilance database for collecting adverse event and medication error reports for drugs and therapeutic biological products post-approval.
What is a Risk Evaluation and Mitigation Strategy (REMS)?
Answer: An FDA-required safety program to manage known serious risks of a marketed drug
REMS is a drug safety program that FDA requires when risk management measures beyond standard labeling are necessary to ensure a drug's benefits outweigh its risks.
Under 21 CFR Part 314.500 (Subpart H), what post-market commitment is required for drugs granted accelerated approval?
Answer: Confirmatory trial to verify the anticipated clinical benefit
Drugs receiving accelerated approval based on a surrogate endpoint must complete a confirmatory trial to verify the anticipated clinical benefit upon which approval was based.