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FDA's Off-label Promotion in Social Media  

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Online Compliance Panel   

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Marketing managers, Regulatory affairs managers, In-house legal counsel, Third-party consultants, Own Label distributors, International trade managers, Product specification developers, Corporate web managers

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Seminar Summary:

FDA regulates firms' use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA's key limitations of how social media can be used. What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA's treatment of social media as labeling opens up a broad opportunity for FDA to claim your product is illegal. Staying within the vague boundaries of FDA's social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media. (see full course description)

 

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Training Course Syllabus:


FDA regulates firms' use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA's key limitations of how social media can be used. What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA's treatment of social media as labeling opens up a broad opportunity for FDA to claim your product is illegal. Staying within the vague boundaries of FDA's social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media.

Objectives of the Presentation

How FDA limits the use of social media
How social media can make your product illegal (misbranded)
Who triggers the off-label trap
Figure out who is responsible for false or misleading information
Identify corporate controls over regulatory affairs and marketing departments

Why Should you Attend

The webinar provides insight on how to manage marketing strategies that use social media. A firm´s use of social media faces FDA restrictions and obligations on how you use social media, what you can say and what you must do to correct misinformation published by third parties that places you at risk with FDA. FDA´s positions shifts over time, so guidance by example provides a clue on what FDA expects, but no clear direction is given. There are key points on how to figure out where the FDA is on this issue and where it is likely to go. Hopefully, you will not be an FDA example of what not to do.

Areas Covered

FDA labeling restrictions on using social media for promotion
Direct to Consumer information obligations
Fair and Balanced information requirements
Context of social media messages
Exemptions for social media use
Management roles and responsibilities

Who Will Benefit

Marketing managers, Regulatory affairs managers, In-house legal counsel, Third-party consultants, Own Label distributors, International trade managers, Product specification developers, Corporate web managers, International trade managers (imports and exports), Marketing and public relations consultants, FDA Quality Assurance (QA) consultants

Seminar Summary:

FDA regulates firms' use of social media to prohibit product information that is deemed false and misleading. Firms bear the responsibility of checking and prohibiting the use of social media that offends FDA's key limitations of how social media can be used. What can be stated by an individual citizen becomes restrict commercial speech when such statements or related information is attributed to a manufacturer. FDA's treatment of social media as labeling opens up a broad opportunity for FDA to claim your product is illegal. Staying within the vague boundaries of FDA's social media restrictions can be confusing, surprising and expensive if you have not carefully charted your course on the use of social media. (see full course description)

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