Conducting Remote Regulatory Assessments—Questions and Answers; Draft Guidance for Industry; Availability

The ANIMAL HEALTH INSTITUTE (AHI) appreciates the opportunity to work collaboratively with FDA to find efficiencies for the regulatory assessment process. We encourage the use of remote regulatory assessments where it achieves the shared goal of efficiency, particularly when resulting in reduced inspections and reduced cost to both industry and the FDA. We recognize that this Q&A complements other recent GFIs published by FDA including Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities; Draft Guidance for Industry and Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Draft Guidance for Industry. As the agency considers the use of remote regulatory assessments, AHI offers the attached questions for further consideration.