Tuesday, January 30, 2024 7:21:37 PM
The FDA must make sure that a drug is safe and effective for a specific use. However, it does not control the decision doctors make about which drugs to use for their patients. This means that once the FDA approves a drug, doctors can prescribe it for any purpose they think makes sense for the patient.
Off-label uses may include using an approved drug
for a different type of cancer than the one it is approved to treat
at a different dose or frequency
to treat a child when it is approved to treat adults
Off-label uses of a drug can become approved uses if the company that makes it obtains approval from the FDA. To gain the added approvals, the company must conduct research studies to show that the treatment is safe and effective for the new uses. However, a company may decide not to invest time and money in this research.
https://www.cancer.gov/about-cancer/treatment/drugs/off-label.
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