FDA Permitted Off-Label Promotion of Regulated Products
Date: March 5, 2025
Time: 12 PM EST
Duration: 60 Minutes
Why should you attend:
If you market FDA-regulated products and have truthful and non-misleading new information for your products, you are now allowed to discuss these new uses without the fear of FDA finding you at fault or a frivolous law suit. However, before you start promoting all uses of your products, on-label and off-label; you must understand the limitations of the new rules. The new rules are not a carte blanche from FDA to manufactures to go around the formal approval process; rather it establishes the limits on both FDA and manufacturers per the new legal environment. This seminar will discuss the current FDA requirements for sharing off-label information with doctors and even patients and their impact on marketing of FDA-regulated products by manufacturers.
Topics Covered in the Session:
- Current FDA accepted definition of off-label, in-label, published and anecdotal information
- FDA guidance documents about off-label promotion
- Review of case-studies from unsuccessful and successful promotion of off-label uses
- Practical tips for training of sales and marketing teams in off-label uses of products
- Regulatory strategies for converting off-label uses to in-label uses
Who will benefit:
This webinar will provide valuable information to:
- 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
Speaker: Mukesh Kumar
PhD, RAC | CEO, FDAMap

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Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
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Your Registration for the workshop is subject to following terms and conditions. If you need any clarification before registering for this webinar please email us at info@fdamap.com
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Cancellations & Substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 5 business days prior to the start date of the event will receive a refund — less a $30 administration fee. No cancellations will be accepted — nor refunds issued — within 5 business days before the start date of the event. You may however, choose to substitute the webinar for which you are registered with some other webinar in the future.
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In the event FDA Map cancels the webinar, FDA Map will issue a full refund to all the registrants for that webinar. Some topics and speakers may be subject to change without notice.