The FDA has issued a new guidance document titled “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers”.
FDA plays a critical
role in protecting the United States from threats such as emerging infectious
diseases, including the Coronavirus Disease 2019 (COVID-19) pandemic. FDA is
committed to providing timely guidance to support response efforts to this
pandemic. FDA has issued this guidance to provide answers to frequently asked
questions about regulatory and policy issues related to inspections, pending
drug applications, and changes in manufacturing facilities for approved
pharmaceutical products.
Posted by Dr. Tim Sandle,
Pharmaceutical Microbiology Resources (http://www.pharmamicroresources.com/)
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Pharmaceutical Microbiology Resources