Approved drugs
Approved Drugs
Approved drugs (/əˈpruːvd drʌɡz/) are medications that have been evaluated and sanctioned by a regulatory authority such as the Food and Drug Administration (FDA) in the United States, the European Medicines Agency (EMA) in the European Union, or the Therapeutic Goods Administration (TGA) in Australia.
Etymology
The term "approved drugs" is derived from the English words "approve" (/əˈpruːv/), meaning to officially agree to or accept as satisfactory, and "drug" (/drʌɡ/), which refers to a substance used in the diagnosis, treatment, or prevention of a disease.
Related Terms
- Investigational Drug: A pharmaceutical product that is being tested but has not yet received regulatory approval.
- Over-the-counter Drug: A medication that can be purchased without a prescription.
- Prescription Drug: A pharmaceutical substance that requires a medical prescription to be dispensed.
- Generic Drug: A medication that is equivalent to a brand-name product in dosage, strength, route of administration, quality, and performance characteristics, but is sold under its chemical name.
- Brand-name Drug: A drug sold by a pharmaceutical company under a trade name or trademark.
Regulatory Approval
Before a drug can be approved for use, it must undergo rigorous testing in clinical trials to ensure its safety and efficacy. The process begins with preclinical testing in the laboratory and in animals. If the results are promising, the drug moves on to Phase I, Phase II, and Phase III clinical trials in humans. If the drug proves to be safe and effective, the manufacturer can submit a New Drug Application (NDA) or a Biologics License Application (BLA) to the regulatory authority for review. If the authority approves the application, the drug can be marketed to the public.
External links
- Medical encyclopedia article on Approved drugs
- Wikipedia's article - Approved drugs
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