FDA Guidance for Industry: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

FDA Guidance for Industry: Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications

The purpose of this guidance is to provide information to applicants on how FDA intends to use alternative tools to assess manufacturing facilities identified in a marketing application (i.e., a 19 new drug application (NDA), an abbreviated new drug application (ANDA), a biologics license application (BLA), or a supplement to any of these types of applications)