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FDA to Resume Domestic Inspections with New Safety Measures after Temporary Pause Due to COVID-19 Health and Safety Concerns

On March 18, 2020, the United States Food and Drug Administration (FDA) announced the suspension of all domestic routine surveillance facility inspections until further notice. FDA took this measure to protect the health and well-being of its staff and those who conduct the inspections for the agency under contract at the state level, and due to industry concerns regarding visitors. During this interim period, the FDA conducted only a limited number of mission critical inspections using a risk-based approach. On July 10, 2020, FDA announced its plans to resume on-site inspections during the week of July 20th with the assistance of a newly developed COVID-19 Advisory Rating System for assessing the risk of carrying out an inspection in a particular location.

The Advisory Level uses real-time state and national data on the number of COVID-19 cases, and based on the outcome of three metrics, helps to identify those geographic regions in which domestic inspections can restart. The metrics are: Phase of the State (as defined by White House guidelines), statistics measured at the county level to gauge the current trend in infections, and intensity of infection. The agency further stated that its ability to restart on-site inspections also depends on other factors impacted by the pandemic, such as availability of public transportation and downward trends in new cases of COVID-19.

Additional guidance on resuming inspections is anticipated to come soon, but for now entities should be aware that prioritized domestic inspections will resume in the coming weeks, but they are anticipated to be pre-announced for the foreseeable future.

This article features contributions from Sanchita Bose.

©2020 Epstein Becker & Green, P.C. All rights reserved.National Law Review, Volume X, Number 196

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About this Author

Amy K. Dow, Health care, life sciences, attorney, Epstein Becker, law firm
Member

Amy K. Dow is a Member of the Firm in the Health Care and Life Sciences practice, in the firm's Chicago office.

Ms. Dow: Counsels clients regarding the research, approval, sale and promotion of pharmaceuticals, biologics and medical devices; Drafts and negotiates agreements with providers of clinical and non-clinical development services; and more.

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