The U.S. Food and Drug Administration (FDA) held a webinar last week to discuss three recently released guidance documents related to regulatory requirements for pharmaceutical and medical device manufacturers, distributors and packers that use social media and the internet to promote FDA-approved products. The FDA has made the PowerPoint and webinar Q&As publicly available for review. Specifically, as we informed you here and here, the FDA issued the following three draft social media guidance documents:
Interested parties have opportunities until September 16, 2014 to provide comments to the Draft Guidance for Industry and Staff: Internet/Social Media Platforms with Character Space Limitations; Presenting Risk and Benefit Information for Prescription Drugs and Medical Devices and Draft Guidance for Industry and Staff: Internet/Social Media Platforms; Correcting Independent Third-Party Misinformation About Prescription Drugs and Medical Devices. Interested parties should carefully review all documents to determine whether there are key areas that should be addressed.