CRAP CRAP Post-Market Surveillance & Vigilance 1

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

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?

Accepted Answer

15 calendar days

Answer

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'?

Accepted Answer

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

Answer

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?

Accepted Answer

FAERS (FDA Adverse Event Reporting System)

Answer

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)?

Accepted Answer

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

Answer

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.

(CRAP) Certified Regulatory Affairs Professional Practice Test

(CRAP) Certified Regulatory Affairs Professional Practice Test

CRAP CRAP Post-Market Surveillance & Vigilance 1