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FDA issues COVID-19 Vaccine Guidance

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FDA issues COVID-19 Vaccine Guidance

On June 30, 2020 FDA issued a new guidance on Development and Licensure of Vaccines to Prevent COVID-19. The guidance sets regulatory expectations for the manufacture, non-clinical, clinical and post-licensure [...]

Antibody-Dependent Enhancement Risk for SARS-CoV-2 Vaccine Developers

This article explores a phenomenon called Antibody-Dependent Enhancement (ADE).  This occurs when binding of a virus to non-neutralizing antibodies enhances its entry into host cells, and sometimes also its replication. The [...]

Pre-IND Meeting Requests for COVID-19 Products

Given the numerous inquiries from prospective sponsors interested in conducting clinical trials for COVID-19 products, FDA has issued new guidance to assist sponsors in preparing Type B pre-investigational new drug [...]

Kamalpreet Arora, PhD

Eleven years of research review experience working in Office of Biotechnology Products, CDER, FDA. Three years of working as Science and Standards Liaison of Biologics at United States Pharmacopeia. Extensive [...]

CGMP Compliance Challenges with COVID-19 Infection

With the advent of Coronavirus (COVID-19) disease as a public health emergency, FDA has issued new guidance on COVID-19 infection in employees [Good Manufacturing Practice Considerations for Responding to COVID-19 [...]

Ken Guito, MBA

Kenneth Guito, MBA was hired as Chief Operating Officer (COO) of Biologics Consulting Group, Inc. in 2019, following a 35-year career in the Biotech/Biopharmaceutical Industry. Prior to joining Biologics Consulting, [...]