Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency — Guidance for Industry

On 14 April 2021 the FDA issued the final guidance on remote evaluations of drug manufacturing and bioresearch monitoring facilities during COVID-19.

FDA is issuing this guidance to describe how they will request and conduct voluntary remote interactive evaluations at facilities where drugs are manufactured, processed, packed, or held; facilities covered under FDA’s bioresearch monitoring (BIMO) program; and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act) for the duration of the COVID-19 public health emergency.

Read more online 
Copyright Widler & Schiemann AG 2020. All Rights Reserved. /