2012 - FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion: What is Acceptable or Not Acceptable? - Webinar By GlobalCompliancePanel

Overview: This webinar is intended to discuss the best 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). This webinar will also discuss the best practices for responding to both non-public and public unsolicited requests made through emerging electronic media (e.g., social media or other public electronic media).
Pursuant to the Act and applicable federal regulations, firms (e.g., drug or medical device manufacturers) are prohibited from disseminating information of any new intended use (off label information) that has not determined to be safe and effective or that is outside FDA's substantial equivalence termination (clearance) for devices requiring premarket notification [section 510(k) of the Act] requirements. Statements made in a way to promote a drug or medical device for uses other than those approved or cleared by FDA may constitute "evidence of a new intended use." It is imperative that firms understand and accurately interpret the statutory provisions and FDA regulations governing label, labeling and off-label promotion within the meaning and scope compliant with the FDA’s current thinking and the applicable statutory and regulatory requirements.
Why should you attend:If you don’t know the answers to the following questions, you should attend the seminar:
Regarding label and labeling, what statutory provisions are applicable?
Regarding label and labeling, what FDA regulations are relevant and applicable?
Definitions of label and labeling?
Definitions of public and non-public unsolicited requests for off-label information?
Differences between the solicited requests and unsolicited requests?
How to disseminate off-label information?
How to respond to non-public or public unsolicited requests for off-label information about FDA-approved or cleared products (drugs and medical devices)?
The said "unsolicited requests" are those made through electronic social media (product websites, discussion boards, chat rooms, twitter, LinkedIn, YouTube, online forum, or other public electronic forums)?
What are FDA's current recommendations to firms wishing to respond to public and non-public unsolicited requests for off-label information?
What are the best practices for disseminating off-label information responding to public and non-public unsolicited requests?
What is acceptable?
What is not acceptable?
Who should and should not handle the unsolicited requests for off label information and how to respond?
Areas Covered in the Session:
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?
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 "off-label" promotion.
Discuss FDA guidance documents: FDA's policy and recommendations to firms wishing to respond to unsolicited requests for off-label information.
Recent enforcement actions
Speaker's practical, actionable and strategic solutions to respond: "CAC-SI" method
Who Will Benefit:
Regulatory Affairs Managers, Directors and VPs
Clinical Affairs Managers, Directors and VPs
Quality Managers, Directors and VPs
Quality Managers, Directors and VPs
Compliance Managers and Directors
Sales and Marketing Managers, Directors, and VPs
Complaint Handling and Risk Management Managers and Directors
Site Managers, Directors, and Consultants
Senior and Executive Management
Compliance Officers and Legal Counsel
Business Development Managers, Directors, and VPs
Price List:
Live : $245.00
Corporate live : $995.00
Recorded : $295.00
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Phone: 800-447-9407
Fax: 302-288-6884