2016 - Webinar on FDA Off-Label Promotion Guidelines

Description :
Many FDA approved products have uses beyond what they have been approved for. Manufacturers have to follow very strict guidelines to inform physicians about these additional uses. Manufacturers also have to deal with consumers directly asking for more information about such uses. This seminar will discuss FDA-acceptable practices to collect, distribute and manage off-label information about FDA-approved products.
Practical advice based on multiple case studies regarding off-label promotion for products by manufacturers. Attendees will get a list of do’s and don’ts for discussing published material, clinical experience, investigational uses, and anecdotal information. Social media techniques will also be discussed.
Areas Covered in the Session :
FDA-permitted off-label promotion techniques
FDA guidance about off-label information management
What is an Off-Label Use?
Pros and cons of common methods for off-label promotion
Converting off-label to on-label information
Do’s and don’ts of social media techniques in off-label promotion
Legal Vs Regulatory Paradigms
Commercial Promotion of Off-Label Use
Common Myth: FDA Does not Allow Off-Label Use
Regulation of Advertisement
Request for Off-Label Information
Do’s and Don’ts for Responding to Unsolicited Request
Risks with Soliciting information
Distributing Peer-Reviewed Published Literature
Common Complaints from FDA
What to Expect in the Near Future
Speaker’s Recommendation and Suggestions on PASS-IT Solutions
Conclusion
Who Will Benefit:
Manufacturers of FDA regulated products: Drug, Medical Device and Biotech Companies, Dietary supplement manufacturers
Marketing and Advertising Professionals
Financial analysts and investors, venture capitalists, insurance professionals
Legal experts involved in advising manufacturers of marketed products
Senior management for companies developing new products for US market
Regulatory affairs professionals, research analysts