How The US FDA Finds Pre-Approval Inspection Alternatives During COVID-19 Pandemic

16 Jul 2020

Officials explain how remote record reviews, site transfers and other factors can green-light approvals of drugs and biologics.

Pharmaceutical industry. Male factory worker inspecting quality of pills packaging in pharmaceutical factory. Automatic tape to create packaging and filling of medicines. control in the factory of — more approvals without inspections during pandemic? • Source: Shutterstock

The US Food and Drug Administration has approved more than a dozen product submissions using alternative tools in place of site inspections that would normally be a condition of approval but are difficult or impossible to conduct during the COVID-19 pandemic.

Agency officials have been carefully reviewing whether and how to conduct pre-approval inspections for the steady stream of drug applications...