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FDA Regulation of Medical Foods

Tuesday, June 21, 2016
Time: 2:00 pm EST - 3:00 pm EST
Cost: $250.00

Webinar 1 CCS Credit

Medical foods are subject to specific regulatory requirements by the Food and Drug Administration, but determining whether an item is regulated as a medical food or as a food, dietary supplement or drug can be confusing. This webinar will highlight the differences between these products, clarify the existing regulatory landscape for medical foods and offer suggested compliance practices.

Key Topics

- regulatory overview of medical foods

- applicable laws and regulations

- key legal considerations and issues

- product claims

- FDA guidance

- substantiation

- compliance protocols

Our Speaker

Shelly Garg is an attorney with Sandler, Travis & Rosenberg’s Food and Drug Law Practice Group. She represents clients across a broad range of FDA-regulated product categories, including food, beverages and dietary supplements, over-the-counter drugs, medical devices, and cosmetics. She advises in strategic business planning, product development, testing and approval, labeling, advertisement and promotion, liability risk, inspections, responding to regulatory enforcement matters, and related issues. Her keen insights into the FDA and its inner workings have proven to be of significant value to her clients in successfully resolving matters before the agency.

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