CRAP CRAP Post-Market Surveillance & Vigilance 1 — Questions and Answers
Question 1: What is the primary purpose of FDA's MedWatch program?
- To conduct pre-approval clinical trials for new drugs
- To collect voluntary safety reports on adverse events from marketed products (Correct answer)
- To approve new drug applications submitted by manufacturers
- To regulate pharmaceutical advertising to healthcare providers
Correct 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.
Question 2: Under 21 CFR Part 314.81, what is the required timeframe for an NDA holder to submit an expedited 15-day alert report?
- 7 calendar days
- 15 calendar days (Correct answer)
- 30 calendar days
- 45 calendar days
Correct 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.
Question 3: Under FDA regulations, which outcome qualifies an adverse event as 'serious'?
- Any event requiring a pharmacy visit
- Death, life-threatening condition, hospitalization, disability, or congenital anomaly (Correct answer)
- Any event reported by more than 1% of patients in a clinical trial
- An event requiring a dosage adjustment
Correct 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.
Question 4: Which FDA database is used for post-market surveillance of adverse events for drugs and biologics?
- MAUDE (Manufacturer and User Facility Device Experience)
- FAERS (FDA Adverse Event Reporting System) (Correct answer)
- TPLC (Total Product Life Cycle database)
- eCTD (Electronic Common Technical Document)
Correct 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.
Question 5: What is a Risk Evaluation and Mitigation Strategy (REMS)?
- A pre-approval risk assessment required for all new drug applications
- An FDA-required safety program to manage known serious risks of a marketed drug (Correct answer)
- A voluntary industry program for tracking post-market adverse events
- A post-market study required for all biologic products
Correct 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.
Question 6: Under 21 CFR Part 314.500 (Subpart H), what post-market commitment is required for drugs granted accelerated approval?
- Phase IV clinical trial for a new indication
- Confirmatory trial to verify the anticipated clinical benefit (Correct answer)
- Bioequivalence study comparing to a reference listed drug
- Pharmacovigilance study only, with no efficacy requirement
Correct 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.
CRAP CRAP Post-Market Surveillance & Vigilance 1
What is the primary purpose of FDA's MedWatch program?