A Client Reports an Adverse Effect to the Adverse Event

question 34

Multiple Choice

A client reports an adverse effect to the Adverse Event Reporting System.The nurse recognizes if a potential safety concern is identified,the Food and Drug Administration (FDA) may take which actions?
Select all that apply.

• A)Determine the extent of the safety concern by conducting additional studies
• B)Require changes be made to the product's labeling information
• C)Recall the product
• D)Restrict the product's use in certain populations
• E)Continue to log in public concerns regarding the safety of the product before taking further action

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Definitions:

Pressure Group System

Networks of interest groups or lobbying organizations that seek to influence public policy and government decisions without seeking elected office.

Pluralist Theory

A political theory suggesting that power in a democracy is distributed among multiple interest groups, ensuring that no single group dominates the political process.

Corporate Lobbies

Groups funded by corporations that seek to influence lawmakers and government policy decisions in a direction favorable to their interests.

Pluralist Theory

A theory of politics and policy-making that emphasizes the role of diverse, competing interest groups in shaping public policy.