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Health Care and FDA

Health care is one of the largest, most heavily regulated, and most complex industries. Health care providers and companies face enormous challenges navigating through a maze of regulation while at the same time leading the world in advancements in patient care and treatment, medical education and research, and technology.

In today’s era of value-based reimbursement, technological innovation, increasing regulatory complexity and scrutiny, and constantly changing political priorities, health care entities continue to survive and grow through their trademark commitments to excellence, innovation, and global reach. Our health care and FDA team brings similar commitments to the practice of law. We offer practical, swift, and creative solutions to our clients’ legal challenges.

We currently represent health care clients across the care continuum, from premier academic medical centers and hospitals and health systems to home health agencies and hospices, pharmacies, clinical labs, durable medical equipment suppliers, and long-term care providers. Our health care and FDA practitioners also represent leading research and drug development companies, pharmaceutical and medical device manufacturers, and new and emerging digital technologies in all aspects of the development, launch, and marketing of their products. We further advise venture capital funds, private equity funds, and other investors into the health care sector. We have extensive experience providing legal analysis and advice concerning all aspects of health care provider regulation, operations, and transactions. Product and services of our health care company client span the fields of proteomics, genomics, stem cells, bioinformatics, gene and cell therapies, nanotechnology, diagnostics, combinant vaccine development, drug and medical device development, nutraceuticals and food additives, and agricultural biotechnology.

Because each sector of the health care industry has its own unique profile, we bring specialized industry knowledge focusing on understanding core operations and reimbursement pathways. We pride ourselves on delivering strategic, comprehensive, and practical advice grounded in a thorough understanding of our clients' endeavors and goals.

In order to bring to bear the deep, collective knowledge and experience within the firm, our health care and FDA practice has created “health care collaboratives” that include lawyers in other practice areas to focus on certain subspecialty areas or particular health care industry sectors.

Additional Thought Leadership Pages
24 February 2020
K&L Gates Strengthens Global Health Care Practice with Miami Partner Addition
Press Release, Practice & Regional News
16 January 2019
K&L Gates Welcomes Health Care Partner to Research Triangle Park Office
Press Release, Practice & Regional News
17 February 2016
K&L Gates Team Backs $310 Million Pharma Deal
Noteworthy Work
17 February 2016
K&L Gates Names 50 New Partners
Press Release
03 November 2015
K&L Gates Welcomes Chicago Health Care Partner
Press Release

National Tier 1 Ranking in Health Care Law and Biotechnology Law

U.S. News – Best Lawyers® "Best Law Firms" 2020

Recognized by Modern Healthcare as one of the largest dedicated health care practices in the United States.

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