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World of Compliance Module
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Risk Management and Drug Surveillance
abridged
Learning Objectives
Overview
Drug Registration and Listing
Adverse Drug Experience (ADE) Reporting Program
Drug Quality Reporting System (DQRS)
Field Alert Reporting System (FARS)
Drug Product Surveillance Sampling Program
Risk Evaluation and Mitigation Strategies (REMS)
Knowledge Check
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Knowledge Check
For what reason was the Drug Registration and Listing (DRLS) established?
To allow for an orderly categorization of various drug groupings.
To standardize the manufacturing process of generic drugs.
To help protect the public from adulterated and misbranded drugs.
To simplify the task of identifying counterfeit drugs.
Which of the following is not true regarding the Adverse Drug Experience Reporting Program?
Ensures that safety reviewers receive required drug product safety data from the sponsors of approved drugs.
Reviews the periodic mandatory reports that are received from sponsors.
Identifies and analyzes discrepancies in the reporting of adverse effects.
Requires all parties whose names appear on the label to submit reports of adverse effects.
Which of the following is not true of the Drug Quality Reporting System?
It is an obligatory process.
Most reports are received from health care workers.
The FDA receives these reports by mail, phone, fax or internet.
Identified quality issues may require sample collection or result in the issuance of for cause inspection assignments.
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