FDA's issuance of its long-awaited draft guidance on New Dietary Ingredient (NDI) Notification brings game-changing implications to the dietary supplement industry. The guidance provides insight into when a NDI notification is necessary, the type of safety assessment (if any) that must be conducted prior to notification, as well as a number of other suggestions on what to include when filing a NDI notification.
While the guidance represents FDA's comprehensive thinking on NDI notifications, it also raises many legal, scientific and even logistical questions for the industry and FDA.
This workshop will provide valuable insight into the legal aspects of NDI notifications, as well as practical approaches to filing successful NDI notifications and bringing new dietary ingredients to market.
During this panel, Venable partner, Claudia Lewis and others will explore what qualifies as an NDI and when it is necessary to file a notification.
For more information and to register, click here.