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World OF DRUG SAFETY MODULE
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Overview Of Drug Safety
Learning Objectives
Introduction
Risk Management
Epidemiology
Medication Error Prevention and Analysis
Pharmacovigilance – Tools for Risk Assessment and Evaluation
Unapproved Drugs
The Adverse Event
Data Mining
Epidemiology Databases
The Sentinel Initiative
Drug Safety and Risk Management Advisory Committee
Drug Safety Initiatives
Safety First Initiative
International Activities
Knowledge Check
FAQ
Certificate of Completion
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Knowledge Check
The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted FDA the authority to require the submission and implementation of a REMS if FDA determines a REMS is necessary to ensure that a drugs benefits outweigh its risks.
True
False
Utilizing usage data for ___________ has become an area of active growth in the United States and other countries.
Postmarketing studies
Premarketing studies
Scientific studies
What are the terms used for non-proprietary drug names?
Established or Generic
Original or New
Brand or Title
OSE evaluates the properties of marketed medicines.
True
False
What are the two types of adverse event reports for approved drug or biologic products?
Expedited 15-day alert reports and non-expedited adverse event reports
Express alert reports and alert reports
7-day alert reports and adverse event reports
CDER created the Safety First initiative, which states that drug safety is the Center's first priority.
True
False
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Topic: page 1 of 1 (Lesson: page 43 of 52)
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