How to Comply with FDA’s Off-Label Promotion Guidelines

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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 to be Covered:

FDA-permitted Off-label promotion techniques
FDA guidance about off-label information management
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

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

Dr. Mukesh Kumar is a Washington DC-based consultant in regulatory affairs and quality assurance for manufacturers and developers of FDA-regulated products. He and leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD. His key expertise is in regulatory affairs, clinical trials and multinational 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 affairs professional by the Regulatory Affairs Professional Society, USA.

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  • Presentation Handout in .pdf format
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