The U.S. Food and Drug Administration (FDA) is announcing the availability of a temporary guidance for industry entitled, “Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers.” The FDA recognizes the COVID-19 public health emergency is not only impacting public health, but also drug development programs, ongoing manufacturing operations and FDA’s ability to conduct inspections. The FDA also recognizes sponsors and applicants have many questions related to this impact. The agency developed this guidance to provide answers to a number of frequently asked questions.
The Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, and the Office of Regulatory Affairs remain fully capable of continuing daily activities, such as application assessments, including facility evaluation and certain inspection activities, while responding to public health needs related to the current COVID-19 public health emergency. As this remains an evolving and very dynamic situation, the FDA will continue to be flexible and transparent. The questions and answers in this guidance provide information regarding common questions related to inspections for facilities manufacturing pharmaceutical products and sites involved in the conduct of clinical, analytical and nonclinical studies.