NDA Partners Vice President of Operations, Eric Fish, announced today that Stephen Weber, MD, former Medical Officer in the Office of Orthopedic Devices at CDRH, has joined the company as an Expert Consultant. During his FDA career, Dr. Weber conducted reviews of orthopedic devices including upper extremity devices, spine, hip, knee, and ankle devices, combination products, and surgical device products. He was also an active member of the CDRH Working Group on Biological Responses to Metal Implants and involved in regulatory aspects of SMART devices in orthopedics.
Dr. Weber is a board certified orthopedic surgeon with a focus on sports medicine. Prior to his FDA career, he was in private practice at Sacramento Knee and Sports Medicine, where he maintained an active clinical research practice and published numerous papers, articles, and book chapters on orthopedic topics. He is currently an Assistant Professor in the Department of Orthopedics at Johns Hopkins University and consultant to medical device companies.
Dr. Weber’s expertise is in regulatory strategy, regulatory compliance, clinical study design, and medical liability for orthopedic devices, combination products, and surgical device products. According to Deb Koeneman, Manager of NDA Partners’ medical device development practice, “Dr. Weber’s clinical and regulatory expertise will be beneficial to our clients developing therapies and products for orthopedic patients. He is a welcome addition to NDA Partners’ team of medical device consultants.”
Dr. Weber earned his medical degree from the University of Michigan Medical School and conducted his residency and internship at the University of California, Davis. He is an active member of the Arthroscopy Association of North America, American Orthopedic Society for Sports Medicine, International Society of Arthroscopy, Knee Surgery and Orthopaedic Sports Medicine, American Shoulder and Elbow Surgeons, and a fellow in the American Academy of Orthopedic Surgeons.
About NDA Partners
NDA Partners, a ProPharma Group company, is a life sciences management consulting and contract development organization focused on providing product development and regulatory services to the pharmaceutical, biotechnology, and medical device industries worldwide. The highly experienced Expert Consultants in NDA Partners include three former FDA Center Directors; the former Chief Executive Officer and Chief Science Officer at the United States Pharmacopeial Convention (USP); an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, product development program design and management, expert consulting, functional teams, project-based solutions, and clinical trial design and management.
Source : https://www.prweb.com/releases/former_fda_medical_officer_office_of_orthopedic_devices_cdrh_joins_nda_partners_as_expert_consultant/prweb18474495.htm