Responding to Unsolicited Requests for Off-Label Information

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

Instructor Profile:

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 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide.

Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA.

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