FDA Finalizes Guidance on Communications of Scientific Information on Unapproved Uses

Meryl Bartlett, Jennifer Bragg, Monica Groat, Trevor Thompson
Latham & Watkins LLP
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The final guidance describes FDA’s enforcement discretion policy for sharing scientific information on unapproved uses of approved products and suggests a safe harbor for sharing off-label information consistent with the guidance’s recommendations.

Please see full publication below for more information.

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