FDA remote evaluation of drug manufacturing during COVID-19

The US FDA has published guidance on remote interactive evaluation of facilities that are manufacturing FDA-approved drugs during the global COVID-19 pandemic.

In lieu of drug facility inspections, the FDA is relying on information from trusted regulatory partners during the pandemic, and conducting remote interactive evaluations using remote livestreaming videos of operations, teleconferences and/or screen sharing when on-site inspections are not possible due to travel or quarantine restrictions. Remote interactive evaluations have informed the FDA's regulatory decision-making, contributed to ensuring drug quality and helped determine the scope, depth and timing of future inspections.

The FDA has now published new guidance entitled "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency," which describes interactive and virtual tools to provide clarity for regulated facilities on how the FDA will request and conduct remote interactive evaluations during the pandemic. The guidance describes how remote interactive evaluations will be requested and conducted at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed or held; facilities covered under the FDA's bioresearch monitoring program; and outsourcing facilities registered under the Federal Food, Drug, and Cosmetic Act.

The FDA will use existing risk management methods and related tools to determine when to request a facility to participate in a remote interactive evaluation for pre-approval, pre-license, post-approval, surveillance and bioresearch monitoring programs. It will use information from remote interactive evaluations to meet user-fee commitments and to update facilities information, when appropriate. Facilities can choose to decline the FDA's request to perform a remote facility evaluation, but this may delay the agency's ability to make a regulatory decision. The FDA will not accept requests to perform remote interactive evaluations; it will make decisions to offer remote interactive evaluation based on risk and compliance history.