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. In this 90 minutes session, Dr. Mukesh Kumar will discuss the limitations and regulations for discussing, collecting, distributing and managing off-label information about FDA-approved products.
Recent FDA guidelines regarding role of manufacturers in handling unsolicited requests for off-label information will be discussed with practical advice based on multiple case studies. Attendees will get a list of dos and don’ts for discussing published material – both peer-reviewed articles and books, clinical experience, investigational uses, and anecdotal information. Dr. Kumar will also discuss the social media techniques.
A common myth is that FDA bans all off-label uses of drugs, medical devices and biologics. On the contrary 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 seem fit. However, there are strict controls on manufacturers using off-label information to market their products. This session will discuss the regulatory thoughts and practical tips on off-label promotion for the manufacturers. This will also be useful for physicians and patients to understand which information is credible and which illegal.
Topics covered in the session:
Who should attend
Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD (www.amarexcro.com). His key expertise is in regulatory affairs, clinical trials, and multi-national project management for medicinal and diagnostic products. He has been involved in about 100...
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