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FEDERAL REGISTER · NOTICEJuly 9, 2024NOTICE — NO LEGAL EFFECT

Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers; Draft Guidance for Industry; Availability; Agency Information Collection Activities; Proposed Collection; Comment Request

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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.

STATUSNOTICE — NO LEGAL EFFECT
EFFECTIVE—
COMMENTS CLOSESep 9, 2024 · closed
APPLIES TO · SPEQ TAGDrugDevice
Document type
Notice
Agency
Health and Human Services Department
Published
July 9, 2024
Comments close
September 9, 2024
Document number
2024-15009
Docket
FDA-2014-D-0447
ABSTRACT

The Food and Drug Administration (FDA or Agency) is announcing the availability of a revised draft guidance for industry entitled "Addressing Misinformation About Medical Devices and Prescription Drugs: Questions and Answers." This revised draft guidance, when finalized, will describe FDA's current thinking on common questions firms may have when voluntarily addressing misinformation about or related to their approved/cleared medical products. This guidance revises and replaces the draft guidance for industry entitled "Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices" issued in June 2014. This revised draft guidance is not final nor is it in effect at this time.

Abstract as published in the Federal Register.

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