CRAP CRAP Post-Market Surveillance & Vigilance

Question 1

What is the primary purpose of FDA's MedWatch program?

Accepted Answer

To collect voluntary safety reports on adverse events from marketed products

Answer

To conduct pre-approval clinical trials for new drugs

Answer

To approve new drug applications submitted by manufacturers

Answer

To regulate pharmaceutical advertising to healthcare providers

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?

Accepted Answer

15 calendar days

Answer

7 calendar days

Answer

30 calendar days

Answer

45 calendar days

Question 3

Under FDA regulations, which outcome qualifies an adverse event as 'serious'?

Accepted Answer

Death, life-threatening condition, hospitalization, disability, or congenital anomaly

Answer

Any event requiring a pharmacy visit

Answer

Any event reported by more than 1% of patients in a clinical trial

Answer

An event requiring a dosage adjustment

Question 4

Which FDA database is used for post-market surveillance of adverse events for drugs and biologics?

Accepted Answer

FAERS (FDA Adverse Event Reporting System)

Answer

MAUDE (Manufacturer and User Facility Device Experience)

Answer

TPLC (Total Product Life Cycle database)

Answer

eCTD (Electronic Common Technical Document)

Question 5

What is a Risk Evaluation and Mitigation Strategy (REMS)?

Accepted Answer

An FDA-required safety program to manage known serious risks of a marketed drug

Answer

A pre-approval risk assessment required for all new drug applications

Answer

A voluntary industry program for tracking post-market adverse events

Answer

A post-market study required for all biologic products

Question 6

Under 21 CFR Part 314.500 (Subpart H), what post-market commitment is required for drugs granted accelerated approval?

Accepted Answer

Confirmatory trial to verify the anticipated clinical benefit

Answer

Phase IV clinical trial for a new indication

Answer

Bioequivalence study comparing to a reference listed drug

Answer

Pharmacovigilance study only, with no efficacy requirement