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Medical Foods: Understanding what Constitutes a Medical Food for FDA Regulatory Purposes and Strategies for Successfully Commercializing such Products in the U.S.

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This training on medical foods will provide an introduction to FDA’s regulation of medical products, assist you in identifying when it may be appropriate to market a product as a medical food; recommend strategies for marketing such products; and summarize recent FDA enforcement actions in the area to help companies mitigate the risk of potential Agency enforcement action.

Speaker
Instructor: Karl M. Nobert
Product ID: 702508

Why Should You Attend:

The marketing and sale of a medical food is a relatively recent regulatory concept for the FDA. Products now regulated as medical foods were formerly regulated by FDA as drugs until about 1972, when FDA began to consider them as a subcategory of foods for special dietary use.

This webinar will focus on the statutory and regulatory requirements for marketing and selling a medical food in the U.S. It will provide insight into FDA’s interpretation of the above requirements through a discussion of the Federal Register notices and relevant FDA guidance documents supporting this product category.

The session will also focus on FDA’s labeling and promotional rules for medical food products, and provide recommendations for complying with the Agency’s requirements. These recommendations will be based on a review and included discussion of recent FDA enforcement action that have specifically targeted marketed medical foods.

Learning Objectives:

Areas Covered in the Webinar:

Who Will Benefit:

Instructor Profile:

Karl Nobert, is a food and drug regulatory attorney with the law firm of Squire Sanders in Washington, DC. Mr. Nobert provides regulatory advice and counseling to both large and small domestic and international pharmaceutical companies on regulatory issues related to the U.S. Food and Drug Administration’s review and approval of new drug products. This includes counseling clients on FDA’s regulation of prescription branded and generic drugs, and over-the-counter drug products. He also has considerable experience related to the regulation of biologics including cellular and genetic therapies, and veterinary drug products. He frequently presents and has published on such topics.

Topic Background:

The marketing and sale of a medical food is a relatively recent regulatory concept for the FDA. Products now regulated as medical foods were formerly regulated by FDA as drugs until about 1972, when FDA began to consider them as a subcategory of foods for special dietary use. See FDA Advance Notice of Proposed Rulemaking: Regulation of Medical Foods, 61Fed. Reg. 60661, 60662 (Nov. 29, 1996) legal category was formally recognized by Congress in 1988. The law states: The term “medical food” means a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation. See 21 U.S.C. § 360ee(b)(3).

Thus, FDA’s statutory definition of a medical food requires that a product:

FDA has since implemented regulations to clarify the statutory definition of a medical food. Under those regulations, a product is deemed a medical food only if all of the following conditions are met:

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Refund Policy
"Registrants may cancel up to two working days prior to the course start date and will receive a letter of credit to be used towards a future course up to one year from date of issuance.
ComplianceOnline would process/provide refund only if the Live Webinar has been cancelled. The attendee could choose between the recorded version of the webinar or refund for any cancelled webinar. Refunds will not be given to participants who do not show up for the webinar. On-Demand Recordings can be requested in exchange. Webinar may be cancelled due to lack of enrolment or unavoidable factors. Registrants will be notified 24hours in advance if a cancellation occurs."
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