FDA-approved indication
[/ˌɛf.diː.ˈeɪ əˈpruːvd ɪnˈdɪkeɪʃən/]
nounpl: FDA-approved indications
indicação aprovada pela FDA
1. A specific disease, condition, or symptom for which a pharmaceutical drug or medical device has been officially approved by the U.S. Food and Drug Administration (FDA) based on clinical evidence of safety and efficacy
The drug received FDA approval for the indication of type 2 diabetes treatment.
O medicamento recebeu aprovação da FDA para a indicação de tratamento do diabetes tipo 2.
2. The authorized therapeutic use of a medication as determined through rigorous clinical trials and regulatory review
Aspirin has multiple FDA-approved indications including pain relief and cardiovascular protection.
A aspirina tem múltiplas indicações aprovadas pela FDA, incluindo alívio da dor e proteção cardiovascular.
This is a technical term central to pharmaceutical regulation in the United States. FDA-approved indications determine what conditions physicians can legally prescribe a drug for. In Brazil, while the ANVISA (Agência Nacional de Vigilância Sanitária) is the regulatory equivalent, the term 'FDA-approved indication' is commonly used in medical literature and by pharmaceutical companies operating internationally. The concept is crucial for understanding drug safety, liability, and insurance coverage in both countries.
Related Idioms & Phrases
within the approved indication
outside the approved indication
carry an FDA-approved indication for
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