FDA Allowing Additional Comment Period for Draft Social Media Guidances

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The Food and Drug Administration (FDA) is reopening the comment period for two draft social media guidances in response to requests for additional time to allow interested persons to submit comments. Beginning September 29, 2014, the public will have an additional thirty (30) days to provide comments on the following guidance documents: (1) Internet/Social Media Platforms with Character Space Limitations—Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices; and (2) Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

The FDA drafted these guidance documents in response to the increasing use of the internet and various social media platforms by drug and device manufacturers to more actively engage with consumers and healthcare professionals. According to the FDA, these documents represent the agency’s current thinking on specific aspects of their evolving consideration of social media platforms and other Internet-related matters.

Those persons interested in commenting on these guidance documents may submit electronic comments here for the Internet/Social Media Platforms with Character Space Limitations guidance document or here for the Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices guidance document. Written comments may be submitted to the Division of Dockets Management.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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