approval
- Definition
- Once a country's regulatory authority approves a new drug application, the new medicine becomes available for physicians to prescribe. The manufacturing company must continue to submit periodic reports to the regulatory authority, including any cases of adverse reactions and appropriate quality control records. For some medicines, the regulatory authority may require additional studies to evaluate long-term effects.
- Narrower Term
- approval, institutional review boards
- conditional approval
- tentative approval
- Related Term
- application
- approval history
- authorization status
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