Expedited approval
| Expedited approval | |
|---|---|
| Term | Expedited approval |
| Short definition | expedited approval (ak-SEH-leh-ray-ted er-PROO-vul) An official process that allows a new drug to be approved by the US Food and Drug Administration (FDA) before it has gone through all the required human testing. It is only used for medicines that treat serious or life-threatening diseases for which other treatments may be unavailable or no longer effective. |
| Type | Cancer terms |
| Specialty | Oncology |
| Language | English |
| Source | NCI |
| Comments | |
expedited approval - (pronounced) (ak-SEH-leh-ray-ted er-PROO-vul) An official process that allows a new drug to be approved by the US Food and Drug Administration (FDA) before it has gone through all the required human testing. It is only used for medicines that treat serious or life-threatening diseases for which other treatments may be unavailable or no longer effective. A drug can be approved under the accelerated approval process if it has shown certain signs in clinical trials that it could be of benefit to patients, such as: B. a shrinking tumor. More testing of the drug is needed after it receives accelerated approval and is on the market to confirm it really works. Accelerated approval is one way patients can get promising new drugs when other treatment options may not exist
External links
- Medical encyclopedia article on Expedited approval
- Wikipedia's article - Expedited approval
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