Social Media Guidance Webinar – July 10, 2014

The Social Media Draft Guidance Webinar held on July 10, 2014, experienced connection issues.  We recognize the considerable interest in this subject, and we apologize that due to technical difficulties, many registrants were not able to access the webinar. The slides from the webinar are available at the link below.  We have also added questions and answers discussed during the webinar. We invite you to submit comments to the dockets for the draft guidances, also available at the link below. For general questions about the webinar, please send to druginfo@fda.hhs.gov. For specific questions related to the content of the social media draft guidances, please call the appropriate FDA contact as listed on the first page of each of the draft guidance documents.

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Technology is continually changing, but FDA’s commitment to public health does not. In today’s world, a tremendous amount of information exchange occurs on the web and through social media.  In 2014, FDA’s Office of Prescription Drug Promotion released three highly-anticipated draft guidances detailing FDA’s current views and recommendations on specific social media topics.

OPDP, in the Center for Drug Evaluation and Research (CDER) consulted with other FDA Centers, including the Center for Biologics Evaluation and Research (CBER), the Center for Veterinary Medicine (CVM), and the Center for Devices and Radiological Health (CDRH).

To further our communications with stakeholders, media and the public in this area, FDA will host a webinar and Q&A session on July 10, 2014, from 2:00-3:00 p.m. (EST).

We will present an introduction and overview of FDA’s three most-recently issued social media draft guidances:

• Fulfilling Regulatory Requirements for Postmarketing Submissions of Interactive Promotional Media for Prescription Human and Animal Drugs and Biologics

• Internet/Social Media Platforms with Character Space Limitations— Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices

• Internet/Social Media Platforms: Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices.

Subject-matter experts will also be available to answer questions regarding the draft guidances and provide further explanation of key concepts.

Additional information is located at: For Industry: Using Social Media   

• Meeting Slides (PDF- 155KB)
• Social Media Draft Guidance Webinar Question and Answers (July 10, 2014)

To access the public docket or leave comments regarding the draft guidances, please visit:

• Draft Guidance for Industry and Staff: Internet/Social Media Platforms with Character Space Limitations; Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices (FR Notice)
• Draft Guidance for Industry and Staff: Internet/Social Media Platforms; Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices (FR Notice)