CBER Issues First Promotional Untitled Letter Since 2018

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CBER Issues First Promotional Untitled Letter Since 2018

Agency Also Sends First Warning Letter Since 2016 Requesting Corrective Communications

J.W. Schomisch

September 15, 2025 at 12:39 PM EST

FDA’s Center for Biologics Evaluation and Research (CBER) issued its first advertising-related Untitled Letter in seven years on Sept. 9 to AstraZeneca Pharmaceuticals LP in Wilmington, Del., over a direct-to-consumer (DTC) broadcast ad. In addition, the Center sent a Sept. 9 Warning Letter to CSL Behring in King of Prussia, Pa., alleging a direct-to-consumer (DTC) broadcast... Read More

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CBER Issues First Promotional Untitled Letter Since 2018

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