🏭FDA Guidance on Alternative Tools for Drug Manufacturing Assessment
Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications; Guidance for Industry; Availability
Summary
The Food and Drug Administration (FDA or Agency) is announcing the availability of a final guidance for industry entitled "Alternative Tools: Assessing Drug Manufacturing Facilities Identified in Pending Applications." This guidance provides information to applicants on how FDA intends to use alternative tools to assess drug manufacturing facilities identified in a marketing application (i.e., a 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). As part of the negotiations relating to the reauthorization of the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA), as described in "PDUFA Reauthorization Performance Goals and Procedures Fiscal Years 2023 Through 2027" (PDUFA VII commitment letter) and "Biosimilar Biological Product Reauthorization Performance Goals and Procedures for Fiscal Years 2023 Through 2027" (BsUFA III commitment letter), FDA agreed to issue guidance on the use of alternative tools to assess manufacturing facilities named in pending applications and to incorporate best practices from the use of such tools during the Coronavirus Disease 2019 (COVID-19) pandemic. This guidance finalizes the draft guidance of the same title issued on September 22, 2023.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The FDA's guidance on utilizing alternative tools for assessing drug manufacturing facilities impacts compliance and regulatory requirements for businesses involved in drug applications, such as NDAs and BLAs. Companies will need to adapt to these new evaluation methods that incorporate remote assessments, affecting operational strategies and timelines.