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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.

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Tracy Beth Høeg, who is reportedly re-examining Novavax’s COVID vaccine application, is the FDA rep at the CDC panel’s first meeting under the Trump Administration. She raised concerns about routine use of Jynneos for adolescents at risk of mpox and questioned how Moderna assessed efficacy of its COVID vaccines.

FDA Reorganization Proposal A ‘Mindless Approach To Centralization,’ Woodcock Says

 
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