FDA Regulatory

Foley’s highly experienced FDA Regulatory attorneys provide counsel and advise you on food and beverage, drug, biologic, dietary supplements, cosmetic, and medical device development, as well as other regulatory matters that are subject to the jurisdiction of the U.S. Food and Drug Administration (FDA).
Our FDA Regulatory attorneys have the in-depth experience you need to manage your FDA regulatory and compliance matters. We provide comprehensive counseling to companies that are subject to the FDA and its counterpart authorities abroad in all phases of the product development cycle, including strategic business planning, product development and testing, submissions, product marketing, regulatory compliance and enforcement, advertisement and promotion, and legislative branch lobbying at both the federal and state levels. Whether you operate in the food and beverage, drug, dietary supplements, cosmetic, or medical device industry, we have the skills and specialized services needed to serve your FDA-regulated business.

Representative Matters

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A national promotional practices risk assessment for the medical device arm of a Fortune 500 technology company. This arose in connection with an acquisition of an EU-based company that had virtually no compliance practices in place. This is a high-profile matter for the company as the acquisition was a significant strategic investment that may now be at risk.
Represented and counseled a national food producer/food retailer (with more than1500 company-owned or franchise-operated retail outlets) in connection with the national recall of a food product.
Representation of food manufacturer in connection with food regulatory aspects of ongoing acquisition of food production facilities and food ingredients operations.

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