Clinical trials have shown that a new drug alleviates discomfort caused by chemotherapy. The FDA will officially approve the drug next year. Which legislation allows a doctor to prescribe this new drug today?

Compassionate use, also called expanded access, allows a doctor to seek access to an investigational drug for a patient with a serious condition before the drug is FDA-approved. The drug’s expected approval next year does not make it available for ordinary prescribing today. Thus, compassionate use IND is the best choice; off-label use applies to a drug that is already FDA-approved but prescribed for a different purpose.

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