Approval
Approval
Approval (/əˈpruːvəl/) is a term used in various fields, including medicine, to denote the acceptance or endorsement of a particular action, decision, or product. It is often used in the context of regulatory bodies granting permission for the use of new medical devices or pharmaceutical drugs.
Etymology
The term "approval" originates from the Old French word "aprover," which means "to prove, demonstrate."
In Medicine
In the field of medicine, approval is a critical step in the introduction of new treatments and interventions. This process is overseen by regulatory bodies such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in Europe, and the Therapeutic Goods Administration (TGA) in Australia. These organizations review clinical trial data and other evidence to determine whether a new drug or device is safe and effective for its intended use.
Approval can also refer to the acceptance of a treatment plan by a patient or their legal guardian. Informed consent, a process by which a patient is made aware of the potential risks and benefits of a treatment, is a crucial part of this approval process.
Related Terms
- Informed Consent: The process by which a patient or their legal guardian gives their approval for a specific medical intervention.
- Regulatory Approval: The process by which a new drug or medical device is approved for use by a regulatory body.
- Clinical Trial: A type of research study that tests how well new medical approaches work in people. These studies test new methods of screening, prevention, diagnosis, or treatment of a disease.
External links
- Medical encyclopedia article on Approval
- Wikipedia's article - Approval
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