NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Cortez McBerry, a former Lead Reviewer in the FDA Division of Immunology and Hematology Devices in the Office of In Vitro Diagnostics (CDRH), has been appointed as Partner in the firm. Dr. McBerry has worked with the firm since 2021 as Regulatory Consulting Director following his role as Senior Regulatory Affairs Manager at Becton, Dickinson, and Company (BD), Integrated Diagnostic Solutions (IDS).
WASHINGTON, April 20, 2023 /PRNewswire-PRWeb/ -- NDA Partners' Vice President and General Manager, Eric Fish, announced today that Dr. Cortez McBerry, a former Lead Reviewer in the FDA Division of Immunology and Hematology Devices in the Office of In Vitro Diagnostics (CDRH), has been appointed as Partner in the firm. Dr. McBerry is an experienced diagnostics expert with extensive experience in regulatory strategy, regulatory affairs, labeling, and managing US, EU, and Notified Body regulatory submissions for medical devices, and in vitro and companion diagnostics.
Dr. McBerry was formerly a Lead Reviewer in the FDA Division of Immunology and Hematology Devices in the Office of In Vitro Diagnostics (CDRH), where he was responsible for reviewing De Novo requests, PMAs and 510(k) applications for in vitro diagnostic products, reviewing companion diagnostics in IND/BLA applications and in vitro diagnostics in drug/therapeutic labels, conducting meetings with industry, and developing regulatory strategies and policies. Dr. McBerry also served as Senior Regulatory Affairs Manager at Becton, Dickinson, and Company (BD), Integrated Diagnostic Solutions (IDS), in Baltimore, Maryland. While at BD, Dr. McBerry was responsible for the management of the regulatory lifecycle of molecular instruments and assays which included development of regulatory strategy, negotiating with various regulatory agencies, authoring regulatory submissions, and promotional material review. In his early career, he was a post-doctoral fellow with the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH).
According to Dr. Alberto Gutierrez, Manager of the firm's diagnostic device practice, "Dr. McBerry is a diagnostics expert with extensive experience in regulatory strategy, regulatory affairs, and managing regulatory submissions for medical devices, in particular in vitro diagnostics including companion diagnostics. His leadership as Partner will play a critical role as we expand the services and support that we offer clients developing diagnostic products."
Dr. McBerry received his PhD in Immunobiology from the Division of Molecular and Cellular Immunology with the University of Cincinnati/Cincinnati Children's Research Foundation and MS in Microbiology and Molecular Biology and BS in Microbiology from Southern Illinois University.
About NDA Partners
NDA Partners, a ProPharma 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.
Contact
Eric Fish, Vice President & General Manager
Office: 540-738-2550
[email protected]
Media Contact
Eric Fish, NDA Partners, 540-738-2550, [email protected]
SOURCE NDA Partners
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