Drugs

Guidance on Addressing Regulated Product Misinformation

FDA has published a draft guidance, Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers, to respond to common questions firms may have when voluntarily addressing misinformation about or related to their approved or cleared medical products. The document describes existing avenues for communications by firms and also sets out an enforcement policy for certain kinds of Internet-based communications that firms might choose to use to address Internet-based misinformation about or related to their approved or cleared medical products when the misinformation is created or disseminated by an independent third party.

“The recommendations and illustrative examples in this guidance are intended to help support firms that choose to address misinformation about or related to their approved or cleared medical products,” the draft says.

The guidance defines “misinformation” as “implicit or explicit false, inaccurate, or misleading representations of fact about or related to a firm’s approved/cleared medical product.”

FDA says that when finalized, the guidance is intended to advance the agency’s mission to help members of the public get the accurate, up-to-date, evidence-based information they need to inform their decisions about medical products to maintain and improve their health.”

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome