FDA inspections during COVID-19

In Aug 2020, FDA issued a new guidance document "Manufacturing, Supply Chain, and Drug and Biological Product Inspections During COVID-19 Public Health Emergency Questions and Answers". This guidance is aimed to provide answers to frequently asked questions about FDA inspections, pending drug applications, and changes in manufacturing facilities for approved pharmaceutical products during the pandemic.

The big question is : when will FDA resume inspections, foreign and domestic?

According to FDA, the Agency intends to continue using equating existing inspection reports from other trusted foreign regulatory partners through mutual recognition and confidentiality agreements, requesting information from applicants, and requesting records and other information directly from facilities and other inspected entities.

How will FDA prioritize inspections?

FDA’s assessment of whether an inspection is mission-critical considers many factors related to the public health benefit of patients having access to the product subject to inspection. These factors include, but are not limited to, whether the products have received breakthrough therapy designation or regenerative medicine advanced therapy designation, or are products used to diagnose, treat, or prevent a serious disease or medical condition for which there is no other appropriate substitute.