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Responding to Unsolicited Requests for Off-Label Information

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list of dos and don’ts related to social media techniques in off-label promotion.

Why Should You Attend: 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. A common myth is that the FDA bans all off-label uses of drugs, medical devices and biologics. On the contrary, the FDA acknowledges that the unapproved uses may be beneficial to some patients and physicians should be allowed to prescribe FDA regulated products for any off-label use they may deem fit. However, there are strict controls on manufacturers using off-label information to market their products. This webinar will discuss:    

Recent FDA guidelines regarding role of manufacturers in handling unsolicited requests for off-label information Regulatory thoughts and practical tips on off-label promotion for the manufacturers. Limitations and regulations for discussing, collecting, distributing and managing off-label information about FDA-approved products Social media techniques

This webinar will also be useful for physicians and patients to understand which information is credible and which illegal. Attendees will get a list of dos and don’ts for discussing published material – peer-reviewed articles and books, clinical experience, investigational uses, and anecdotal information.

Areas Covered in the Webinar:     

FDA-rules for handling unsolicited questions about off-label information FDA guidance about off-label information management Pros and cons of common methods for off-label promotion Converting off-label to on-label information Dos and don’ts of social media techniques in off-label promotion

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

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Responding to unsolicited requests for off  

This webinar will discuss the FDA guidelines for handling unsolicited requests about off-label information. It will provide attendees a list...