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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

Special Counsel
P +61.3.9205.2046
Senior Associate
P +61.3.9640.4212
Of Counsel
P +852.2230.3503
P +1.412.355.8903
P +1.202.778.9103
P +1.949.623.3540
Special Counsel
P +44.(0)20.7360.8264
P +1.206.370.7947
P +886.2.2326.5125
P +1.212.536.3910
P +1.919.466.1115
P +886.2.2326.5118
P +1.919.466.1127
P +1.919.314.5630
Senior Counsel
P +1.312.807.4430
Senior Associate
P +49.(0)
P +81.3.6205.3609
P +1.919.466.1117
P +61.3.9205.2014
P +1.214.939.6235
Practice Area Leader - Corporate
P +852.2230.3562
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Convinced FDA to reverse its decision on the orphan drug status of an international biopharmaceutical company that obtained; later, successfully defended the client's orphan exclusivity against the competitor's attempt to obtain "clinical superiority" status and break the orphan exclusivity.
Advised a specialty pharmaceutical company on the commercial, managed care, and government pricing issues surrounding the launch of its first FDA-approved drug product.
Advised a pharmaceutical manufacturer on regulatory compliance of all promotional materials.
Medical Devices
Advised device companies and investors on regulatory status of products, estimated time to market, potential submission strategies, and de novo submissions to FDA.
Conducted numerous FDA compliance audits and due diligence reviews for variety of device types, including cardiac assist devices, PACS devices, and GI devices; recent diligence included advising major international device company on $180 million device company acquisition.
Successfully obtained marketing clearance and approval for devices under the 510(k) IDE, PMA, and combination product programs.
Counseled numerous clients on recalls, market withdrawals, and adverse event reports to minimize business disruption, cost, and damage to brands.
Provided regulatory and compliance counseling services to associations representing neurotechnology, device software, and small device manufacturers interests.
Advised a cosmetic manufacturer in developing a global marketing strategy in compliance with U.S. and foreign regulatory requirements.
Reviewed entire fragrance and personal care product line of significant global consumer product company; developed global regulatory checklist for entry into international markets.