REASONS FOR FDA POLICIES ON OFF-LABEL USES:

Permitting Sponsors To Promote Off-Label Uses:

• Would diminish or eliminate incentive to study the use and obtain definitive data.

• Could result in harm to patients from unstudied uses that actually lead to bad results, or that are merely ineffective.

• Would diminish the use of evidence-based medicine.

• Could ultimately erode the efficacy standard.

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