FDA Moves to Keep Key Tools for Remote Checks on Drugmakers

The FDA will continue to use expanded methods of remote evaluations of the drug facilities it monitors adopted during the Covid-19 pandemic, the agency said Wednesday.

The Food and Drug Administration’s draft guidance refers to how the agency requests and conducts voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, compounded, or held under the FDA’s bioresearch monitoring program.

The agency conducts inspections to ensure oversight of FDA-regulated products and assesses facilities in compliance with the Federal Food, Drug, and Cosmetic Act. The FDA introduced alternative tools, such as remote regulatory assessments, for when an inspection ...