As a seasoned medical device and pharmaceutical product liability and regulatory affairs attorney, George has dedicated his career to ensuring that his clients are able to navigate the complex and ever-changing regulatory landscape and mitigate liability with success.
George holds a Ph.D. in Physiology and, prior to joining Phillips Lytle, he was on the faculty in the Department of Physiology and Biophysics at the University at Buffalo School of Medicine. He is also a fellow of the American Heart Association. With over 20 years of experience, he possesses a unique blend of legal, scientific and regulatory expertise that allows him to provide effective and practical advice to his clients.
George’s regulatory affairs practice focuses on advising clients on a range of regulatory matters, including U.S. Food and Drug Administration (FDA) compliance, inspections, product development, clinical trials, labeling, advertising and promotion, and product approval. He has a strong understanding of the regulatory environment, both FDA and European Medicines Agency (EMA), and has successfully guided clients through complex legal and regulatory issues to achieve favorable outcomes as well as avoiding product recalls.
In addition to his regulatory expertise, George has extensive experience in product liability litigation, representing clients in complex litigation matters involving medical devices, pharmaceuticals and other products. He has a deep understanding of the technical and scientific aspects of these products, which enables him to effectively advocate on behalf of his clients.
With exemplary communication and negotiation skills, he has a proven ability to effectively communicate complex legal and scientific issues to clients, as well as to juries, judges and other legal professionals.
George has effectively collaborated with cross-functional teams to achieve regulatory compliance goals, as well as to litigate complex product liability cases. George’s combination of legal, scientific, regulatory expertise, communication and negotiation skills, and leadership abilities makes him a highly valuable asset to any organization looking to navigate the complex and ever-changing regulatory and legal landscape. George is committed to delivering results for his clients and ensuring that their products and operations are in compliance with applicable regulations and laws.
Named Upstate New York Super Lawyers®Rising Star, 2013-2014
Honoree of the New York State Bar Association Empire State Counsel® Program for Pro Bono Work, 2012
Education & Admissions
Education
State University of New York at Buffalo Law School, J.D., 2002
University of Iowa College of Medicine, Postdoctoral Fellow, Department of Medicine, Cardiovascular Center, 1986-1989
State University of New York at Buffalo, Ph.D., 1986
State University of New York at Buffalo, B.A., 1981
Admitted to Practice
New York
Languages
Ukrainian
Experience
Representative Matters
Assisted and counseled companies on pre-enforcement situations; managing FDA inspections; working on responses to FDA-483 observations, untitled letters and warning letters; developing and implementing remediation strategies to correct compliance issues and create corrective and preventative actions (CAPAs).
Advised clients on adverse event (AE/SAE) and medical device report (MDR) reporting, recalls, pharmaceutical root cause analysis and associated issues.
Represented and counseled clients in FDA drug, medical device and biological approval- and clearance-associated matters, such as application submissions (i.e., new drug applications (NDAs), Biologics License Applications (BLAs), abbreviated new drug applications (ANDAs), premarket approvals (PMAs) and 510(k)s), responses to FDA, complete response/deficiency letters, administrative appeals of adverse FDA decisions, and clinical and nonclinical trial design issues.
Counseled and advised drug and medical device developers on lifecycle management issues and opportunities as well as developed regulatory strategy for FDA approval of client products.
Represented clients in matters involving drug and medical device development (i.e., investigational new drug (IND) and investigational device exemption (IDE) issues) and other pre-approval and pre-clearance issues (e.g., Emergency Use Authorizations); FDA expanded access—compassionate use pathway to gain access to an investigational medical product (drug, biologic, or medical device).
Advised companies on labeling, advertising and promotional issues, including the review of promotional pieces, scientific publications and abstracts, policy development regarding off-label uses and associated issues (e.g., handling unsolicited requests for off-label information and good reprint practices), and the development of communication strategies.
Activities and Professional Associations
Present Activities
Ukrainian Home Dnipro Federal Credit Union, Board of Directors
Oncology Research Therapeutics, Inc., Scientific Advisory Board Member
Suneel’s Light Foundation, Board of Directors
Professional Associations
American Association for the Advancement of Science (AAAS)
American Bar Association
Litigation Section
Science & Technology Law Section
American Heart Association / American Stroke Association
Council on Basic Cardiovascular Sciences (Elected Fellow, 2001)
