Short Abstract

This webinar is intended to discuss the FDA-compliant practices for disseminating off-label information by firms for their FDA-approved or cleared products (drugs for both human and animals and medical devices for humans) and in particular, how to respond to both non-public and public unsolicited requests made through emerging electronic media (e.g., social media or other public electronic media).

At the end of the webinar, you will get empowered in a way how you would plan, develop and disseminate medical information including off-label information via the various social media.

The presentation will cover the following areas:

• Review of relevant and applicable statutory provisions.
• Review of implementing FDA regulations.
• Discuss label and labeling within the meaning and scope compliant with FDA’s current thinking.
• Discuss the differences between the solicited requests and unsolicited requests for off-label information.
• Discuss the differences between public unsolicited requests and non-public unsolicited requests.
• Discuss how to disseminate off-label information to the public in a manner acceptable.
• Discuss how to respond to non-public or public unsolicited requests for off-label information about FDA-approved or cleared products (drugs and medical devices) (e.g., requests made through social media or other public electronic media).
• Discuss FDA’s current recommendations to firms wishing to respond to unsolicited requests for off-label information.
• Discuss the best practices for disseminating off-label information responding to public and non-public unsolicited requests.
• What is acceptable and not acceptable?
• Discuss who should and should not respond to the non-public and public unsolicited requests for off label information and how to respond.
• Discuss the nature of the Petition filed on behalf of several drug manufacturers regarding how to disseminate “off-label” information.
• Recent enforcement actions
• Speaker’s practical, actionable and strategic solutions to disseminate off-label information: “CAC-SI” method