FDA Announces Availability of COVID Guidance - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency

FDA Announces Availability of COVID Guidance - Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency   FDA announced the availability of a guidance entitled, "Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency." This guidance describes various interactive and virtual tools we may request to use at a facility to conduct an evaluation. We refer to our use of any combination of these interactive tools as a remote interactive evaluation. This guidance describes how remote interactive evaluations will be requested and conducted for the duration of the COVID-19 public health emergency at any facility where pharmaceutical products, including biological products, are manufactured, processed, packed or held. This includes sites covered under FDA's bioresearch monitoring program and outsourcing facilities registered under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act). FDA will use existing risk management methods and related tools to determine when to request a facility's participation in a remote interactive evaluation. FDA conducts inspections for many purposes and programs, including pre-approval and pre-license, post-approval, surveillance, for-cause and bioresearch monitoring programs. We will consider each of those inspection program areas as possible candidates for remote interactive evaluations. FDA intends to use information from remote interactive evaluations to meet user fee commitments and to update facilities information. Facilities can choose to decline FDA's request to perform a remote facility evaluation; however, this may impede our ability to evaluate the facility or product and make a timely regulatory decision. FDA is using available tools and sources of information to support regulatory decisions and oversight with respect to facilities impacted by FDA's reduced ability to conduct inspections because of COVID-19. For questions about this guidance, please contact the Center for Drug Evaluation and Research at CDER-OPQ-Inquiries@fda.hhs.gov, the Center for Biologics Evaluation and Research at ocod@fda.hhs.gov, the Center for Veterinary Medicine at AskCVM@fda.hhs.gov, or the Office of Regulatory Affairs at ORAPolicyStaffs@fda.hhs.gov.     Manage Subscriptions  |  Unsubscribe All  |  Help This email was sent to ooseims.archieves@blogger.com using GovDelivery Communications Cloud on behalf of: U.S. Food and Drug Administration ·  10903 New Hampshire Ave · Silver Spring, MD ·  20993-0002 ·  1-888-INFO-FDA