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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

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.

Contacts

David L. Rosen
Chair
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Related Services

Additional Resources for FDA-Regulated Companies
We recognize that your business might be affected by FDA requirements even though you do not market FDA-regulated products.
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Congressional Activities on FDA Issues
Our attorneys have legislative experience to help represent you on Capitol Hill whenever the U.S. Congress considers amending the Federal Food, Drug, and Cosmetic Act.
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FDA Application Submissions and Negotiation
When it comes to reviewing your FDA marketing applications for compliance with FDA regulations, we have the experience you need — especially if you are short on manpower, time, or specific knowledge.
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FDA Product Testing and Clinical Research
During the early stages of FDA approval process, we work with you and the FDA to ascertain the nature and quantity of pre-clinical and clinical data required for your particular marketing application.
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FDA Regulatory Compliance and Enforcement
We regularly represent businesses in FDA compliance and enforcement matters, and are equipped to deal with FDA headquarters’ compliance offices and the regional, district, and resident field offices.
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Food, Beverage, and Dietary Supplements
Whether it is human and animal foods, functional foods, beverages, nutraceuticals, or dietary supplements, we have the extensive experience you need for dealing with the FDA, the United States Department of Agriculture (USDA), FTC, and other relevant agencies.
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Global Emerging Technologies Regulation
We have extensive experience in U.S. and international policy relating to the regulation and trade of agricultural commodities, food and beverage, textiles, and plant-based pharmaceutical products derived from biotechnology, as well as of other emerging technologies, most notably nanotechnology.
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International Trade and Strategic Advice for FDA-Regulated Industries
Our highly skilled attorneys will help you stay ahead of the regulatory trends that may impact your business and will help you secure exemptions if necessary.
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Marketing FDA-Approved Products
We want to help you market your products in ways that minimize any potential disruptions by regulators.
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Medical Devices
If you are appearing before the FDA and its counterpart authorities abroad, we can provide you with counsel on all phases of the product development cycle, including pre-clinical activities, clinical trials, the application process, and the post-market environment.
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Pharmaceuticals, Small Molecule, and Biologic/Biotech Drugs
We bring experience in every phase of the regulation of small molecule and biologic/biotech drugs — both prescription and OTC — for your business, including pathway advice, regulatory and compliance issues relating to bulk and finished prescription and OTC drugs, approvals, advertising, marketing, and distribution.
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Strategic Business Planning With FDA
If you are an inventor, company, and/or investor, our attorneys can counsel you on the probable FDA regulatory status and approval pathway for your proposed new products and product concepts, as well as evaluate potential product exclusivities and life cycle evaluation, including IP protection issues.
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