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K&L Gates' FDA practice, focusing on food, drug, device, and cosmetic regulatory and compliance matters, is an experienced and integrated team with a proven track record in all areas the FDA regulates. We help clients navigate the regulatory process throughout the life cycle of their products—from planning and development, to approval and marketing, to enforcement and ongoing compliance.

In addition to addressing regulatory issues after companies have funding and patents in hand, we assist with regulatory due diligence and other transactional needs. Our clients include domestic and international manufacturers and distributors of food, dietary supplement, pharmaceutical, biological, medical device, tobacco, personal care, and cosmetic products, as well as trade associations, individuals, and institutions involved in preclinical and clinical research of FDA-regulated products.

We offer clients multidisciplinary, global, regulatory, and transactional advice to help address FDA, Federal Trade Commission (FTC), Environmental Protection Agency (EPA), Consumer Product Safety Commission (CPSC), and other agency hurdles. We have excellent working relationships across the government agencies that regulate life science companies.

We Understand the Science
Our FDA team not only has significant legal and regulatory experience, but many of us have scientific degrees in areas such as biology, molecular biology, neuroscience, and engineering, as well as first-hand experience with biomedical research. As the scientific landscape continues to evolve, we have the knowledge necessary to assist clients with the regulatory challenges affecting new drugs, monograph drugs, alternative medicines and therapies, medical devices, radiological products, food, nutraceuticals, dietary supplements, medical food, cosmetics and other personal care and “combination” products.

Our Global Platform
K&L Gates’ global platform allows our FDA team to offer domestic, international, and multinational companies 24/7 availability and a unique position from which to advise on research, approval, registration, import, export, and recall matters involving FDA-related issues on the East and West coasts of the United States, as well as throughout Canada, the European Union (EU), Japan and the Pacific Rim, Latin America, and other markets.

Areas of Practice

NameTitleOfficeContact
Associate
P +65.6507.8187
Special Counsel
P +61.3.9205.2046
Of Counsel
P +852.2230.3503
Partner
P +1.949.623.3540
Special Counsel
P +44.(0)20.7360.8264
Partner
P +1.206.370.7947
Administrative Partner (Taipei)
P +886.2.2326.5125
Partner
P +1.212.536.3910
Partner
P +1.919.466.1115
Partner
P +886.2.2326.5118
Partner
P +1.312.807.4430
Partner
P +61.3.9205.2014
Counsel
P +1.919.743.7341
Associate
P +44.(0)20.7360.8270
Of Counsel
P +1.919.466.1117
Associate
P +1.214.939.6235
Associate
P +1.919.314.5609
Partner
P +852.2230.3562
Showing 1-10 of 29 results
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Food
Assisted with the development and launch of functional food, medical food, and dietary supplement products, including review of labels, labeling, and other marketing material to ensure compliance with all applicable FDA, USDA, and FTC requirements.
Assisted food processors, supplement companies, distributors, and retailers in responding to FDA inspection issues and in GMP, HACCP and other forms of regulatory compliance.
Advised dietary supplement manufacturers on scientific substantiation of labeling claims, including development of research protocols to obtain data to support structure/function claims.
Provided regulatory and other counseling to associations representing food ingredient, processing and packaging interests.
Successfully established safety and suitability of various food ingredients through Food Additive Petitions, GRAS Notifications, Dietary Ingredient Notifications, and other appropriate procedures.
Assisted companies in negotiating releases of imported products or ingredients detained by FDA or U.S. Customs.
Provided comprehensive crisis management assistance in numerous food recalls.
Drugs/Biologics
Advised start-up companies on filing 505(b)(2) applications, FDA regulation, HIPAA, and state regulatory requirements relating to drug pricing, distribution and promotion programs.
Represented an innovator pharmaceutical company with the state and federal legal issues surrounding the Rx-to-OTC switch of a major drug product; conducted multi-state surveys to support research.
Provided regulatory and other counseling to clinical investigators, medical centers, and associations representing Institutional Review Boards (IRB).