KeiS a medical professional

This is a blog about the scientific basis of medicine. A judo therapist reads research papers for study and writes about them.

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FDA releases roadmap for inspection and assessment activities during a pandemic

Wednesday, May 5, 2021

News

Today, the U.S. Food and Drug Administration issued a report entitled "Resilience Roadmap for FDA Inspectional Surveillance". The report describes inspection activities during the COVID-19 pandemic and priorities related to this work going forward.

The report is intended to provide the public with a transparent overview of future plans, both successes and challenges faced, due to the pandemic over the past year, and to ensure that Americans continue to have access to safe food and quality FDA-regulated products.

And the report emphasizes the following

From March 2020 through March 2021, FDA conducted a total of 821 mission-critical inspections, including 29 overseas.

In addition, since the reopening in July 2020, a total of 777 priority domestic inspections have been conducted.

Of the more than 13,500 applications for drug approvals or authorizations received since March 2020, an estimated 68 applications have been postponed due to the inability to conduct inspections, the majority of which are not considered mission critical.

In addition, the report outlined ongoing steps the agency is taking to resume standard operating levels of testing activities, including how to prioritize domestic and international testing that was not conducted during the pandemic.

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