[09/21/2023] Today, FDA issued new guidance on how the agency intends to use alternative tools in advance or in lieu of an inspection to remotely evaluate drug manufacturing facilities named in pending applications as part of FDA’s drug review process.
FDA uses a risk-based approach to determine if alternative tools, including requesting records from manufacturers, remote interactive evaluations of facilities, and receiving information from foreign regulatory partners, may be used.
“Today’s guidance will help the agency maintain operational flexibility to support review of drug applications and facility evaluations which could result in timely approval of drugs and facilitate the availability of new, generic, and biosimilar drugs for patients,” said Michael Kopcha, Director of FDA’s Office of Pharmaceutical Quality. “FDA successfully used alternative tools to evaluate facilities during the COVID-19 pandemic, and we will continue to use these tools when and where appropriate.”
FDA uses alternative tools to help the agency confirm that manufacturers can implement and control the proposed operations described in the drug application to consistently produce high-quality drugs. These alternative tools complement inspections but are not considered inspections. Generally, alternative tools may be used when FDA determines the use of the tool may enable oversight and assessment activities in advance, in lieu, or in support of an inspection.
This guidance does not apply to other drug inspection programs such as postapproval inspections, surveillance inspections, follow-up and compliance inspections, and bioresearch monitoring inspections.
The agency has previously issued other guidance on remote oversight tools.
- Conducting Remote Regulatory Assessments Questions and Answers
This draft guidance provides answers to frequently asked questions regarding what remote regulatory assessments are, when and why FDA may use them, and how FDA may conduct them, among others. This guidance applies to all FDA-regulated commodities (drugs, foods, cosmetics, etc.)
- Remote Interactive Evaluations of Drug Manufacturing and Bioresearch Monitoring Facilities During the COVID-19 Public Health Emergency
This guidance describes how remote interactive evaluations were requested and conducted at facilities manufacturing or handling drugs, bioresearch monitoring facilities, and outsourcing facility drug compounders during the COVID-19 public health emergency. This guidance is intended to remain in effect until November 7, 2023.