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