OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus

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OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus

J.W. Schomisch

January 23, 2024 at 01:42 PM EST

The first Untitled Letter of 2024 issued by the FDA’s Office of Prescription Drug Promotion (OPDP) continues the agency’s concern over efficacy claims. In a Jan. 18 Untitled Letter to Novartis Pharmaceuticals Corp, East Hanover, N.J., OPDP questioned the efficacy claims made for Kisqali (ribociclib) tablets, for oral use in a Direct-to-Consumer (DTC) television advertisement.... Read More

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OPDP Issues First Untitled Letter for 2024; Efficacy Claims Continue as Agency Focus

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