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
For more info, fill the box below. We will contact you within 24 hrs.
Webinar Fee
Prices are in US Dollars.
The registration fee includes: The live webinar & all related course materials.
Terms & Conditions to register for the Webinar
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
Payment
We accept credit card, debit card, and PayPal.
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.
On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($30) will be transferred to any future FDA Map event and a credit note will be issued. No-shows will be charged the full amount.
Webinar material will be uploaded on the website 24 hours before the scheduled date of the webinar. In case it is not available on the website due to some technical issues, we will email the material a few hours before the start of the webinar.
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.
