News & Insights
July 1, 2020 •
Blog
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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 application (pre-IND) meeting requests for COVID-19 related drugs and biologics1. This…
June 25, 2020 •
Blog
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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 Infection in Employees in Drug and Biological Products Manufacturing/ Guidance for Industry…