The U.S. Food and Drug Administration (FDA) is a federal agency responsible for protecting public health by ensuring the safety, efficacy, and security of drugs, biological products, and medical devices. It also oversees the nation's food supply, cosmetics, and products that emit radiation.
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The FDA approves new drugs through a rigorous evaluation process to ensure they are safe and effective for their intended use.
Nurses must understand FDA guidelines for drug administration to ensure patient safety and compliance with legal standards.
FDA regulations require healthcare providers to report adverse drug reactions and medication errors.
The FDA classifies drugs into schedules based on their potential for abuse and medical use, which affects how they are prescribed and dispensed.
For diabetic medications, the FDA monitors ongoing clinical trials and post-marketing surveillance to gather data on long-term effects.
Review Questions
What role does the FDA play in the approval of new medications?
Why is it important for nurses to be familiar with FDA guidelines when administering drugs?
How does the FDA influence the classification of controlled substances?
Related terms
Drug Approval Process: A series of steps taken by the FDA to evaluate a new drug's safety and effectiveness before it can be marketed.
Adverse Drug Reaction (ADR): Any unintended or harmful reaction experienced after the administration of a drug or combination of drugs under normal conditions.
Controlled Substance Schedules: Categories established by the Controlled Substances Act (CSA) that classify drugs based on their acceptable medical use and potential for abuse or dependency.
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