Live Webinar
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FDA Compliance for Drug and Medical Device Labeling and Off Label Promotion: What is Acceptable or Not Acceptable?
Date & Time: Wednesday, March 14, 2012
10:00 AM PST | 01:00 PM EST
Duration: 60 Minutes
Instructor: David Lim
Location: Online
Price : $245.00
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(for one participant)
Instructor Profile:
Overview:
David Lim Chairman and CEO, Regulatory Doctor
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
Dr. Lim obtained his Ph.D. in biological sciences at the University of Missouri-Columbia and published his thesis research in the prestigious journal “Science.” Since then, Dr. Lim has held various positions at Duke, US National Laboratories, Intrexon Corporation, Terumo, US FDA/CDRH, and EraGen Biosciences, Inc., A Luminex Company. In 2009, Dr. Lim served as a member during the FDA’s Transparency Public Meeting. Prior to founding his own consulting firm (www.RegulatoryDoctor.com), Dr. Lim was Senior Vice President of Scientific and Regulatory Affairs at Aquavit Pharmaceuticals, Inc. in New York, wherein Dr. Lim provided inspiring and actionable solutions for sustainable business operation. ...more
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.
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Review of relevant and applicable statutory provisions.
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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
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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
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