FDA Proposes Risk-Based and Remote Inspection Strategies in New Report
By EsqSocial Corporation 10/05/21
On May 5, 2021, the U.S. Food and Drug Administration (FDA) issued a much-anticipated report, “Resiliency Roadmap for FDA Inspectional Oversight,” which provides a roadmap for the agency’s post-pandemic plans to return to a consistent state of inspection operations. For the near term, FDA reports that it will continue to prioritize critical inspections of both domestic and foreign facilities, including preapproval inspections for priority products and inspections in reaction to recalls or other...
By: Sheppard Mullin Richter & Hampton LLP