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US FDA Clarifies ‘Intended Use’ Policy For Approved Products

 
• By Brenda Sandburg

‘Totality of evidence’ establishes that a manufacturer intends a drug to be used for unapproved conditions, agency says; PhRMA says final rule disregards multiple courts’ protection of free speech.

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Stakeholders were concerned when FDA slipped changes to its “intended use” regulations into a 2015 proposed rule on tobacco-derived drug products. While the agency has modified the regulatory language, it continues to require manufacturers to specify in labeling how a product is intended to be used.

The agency clarifies its position on the types of evidence that may be considered in determining a medical product’s intended...

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