Healthcare and FDA
Healthcare is one of the largest, most heavily regulated, and most complex industries. Healthcare 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, healthcare entities continue to survive and grow through their trademark commitments to excellence, innovation, and global reach. Our Healthcare and FDA practice group brings similar commitments to the practice of law. We offer practical, swift, and creative solutions to our clients’ legal challenges.
We currently represent healthcare 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 Healthcare 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 healthcare sector. We have extensive experience providing legal analysis and advice concerning all aspects of healthcare provider regulation, operations, and transactions. Product and services of our healthcare 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 healthcare 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 Healthcare and FDA practice has created “healthcare collaboratives” that include lawyers in other practice areas to focus on certain subspecialty areas or particular healthcare industry sectors.
340B Program and Pharmacy
Academic Medical Centers (AMCs)
Clinical Integration and Accountable Care
Food, Drugs, Medical Devices, and Cosmetics (FDA)
Healthcare Employment
Healthcare Fraud and Abuse (U.S.)
Healthcare Payor-Provider Disputes (U.S.)
Healthcare Transactions
Hospitals and Health Systems
International Healthcare
Medicare Reimbursement and Enrollment
Chambers
Ranked by Chambers USA for Healthcare: Highly Regarded, 2024
Ranked as a Band 1 firm by Chambers USA for the tenth consecutive year for Healthcare in North Carolina, 2024
Legal 500
Ranked by The Legal 500 United States for Healthcare: Service Providers, 2024
Ranked by The Legal 500 United States for Healthcare: Service Providers, 2023
Other Recognitions
Ranked by Modern Healthcare’s Largest Healthcare Law Firms Survey as the 17th largest dedicated healthcare law practice in the United States, 2024
