On Sept. 21, 2023, FDA released a new guidance on how the agency plans to utilize alternative tools to remotely evaluate drug manufacturing facilities identified in a marketing application. The application may be a new drug application, an abbreviated new drug application, a biologics license application, or a supplement to any of these applications. These tools include requesting records from manufacturers, remote interactive assessments of facilities, and receiving information from foreign regulatory partners. During the COVID-19 pandemic, FDA was able to use alternative tools to evaluate facilities; now, it intends to continue to use those tools when appropriate. This guidance is intended to assist FDA in keeping operational flexibility and bolstering faster availability of new, generic, and biosimilar drugs for patients.
