drug withdrawal
- Guideline or reference source
- FDADST An FDA Guide to Drug Safety Terms
- Definition
- In rare cases, FDA may need to reassess and change its approval decision on a drug. A conclusion that a drug should no longer be marketed is based on the nature and frequency of the adverse events and how the drug's benefit and risk balance compares with treatment alternatives. When FDA believes that a drug's benefits no longer outweigh its risks, the agency will ask the manufacturer to withdraw the drug.
- Related Term
- withdrawal application
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