FDA updates Q&A Guidance on Inspections and Applications

Recommendation

13/14 June 2023
Vienna, Austria

GMP and Quality Requirements for Radiopharmaceuticals

After the publication of the Guidance for "Remote Interactive Evaluations", FDA has updated its "Manufacturing, Supply Chain, and  Drug and Biological Product  Inspections During COVID-19 Public  Health Emergency Questions and Answers Guidance for Industry", clarifying some of the plans to take when the agency cannot conduct an onsite inspection of a facility. FDA acknowledges the fact that on-site inspection activities are "limited due to factors including travel restrictions" and "intends to continue using alternative tools, when appropriate, to evaluate facilities".

The document explains what FDA deems as "mission-critical" and how it will ensure the quality of imported products while inspections are limited.

How will limited inspection activities affect applications?

FDA states that it is "using all available tools and sources of information to support regulatory decisions on applications that include sites impacted by FDA's ability to inspect due to COVID-19." Examples:

• FDA will continue the quality assessment of all applications per normal assessment operations (using a risk-based approach).
• Additional tools will be used wherever possible (review of the compliance history, using shared information from other foreign agencies, requesting records "in advance of or in lieu of" facility inspections).
• FDA will continue to work directly with the applicants and encourages those "to be in communication with all their facilities and sites to ensure timely responses to any inquiries".

What if an application includes sites that cannot be inspected because of travel restrictions?

FDA will not automatically send out a complete response (CR) letter to the applicant if FDA cannot conduct an inspection. "Decisions regarding applications will be based on the totality of the information available to FDA", this includes information obtained from use of the tools described in the Guidance. Decisions will then be made on all the available information. This can lead to the following decisions:

• FDA plans to approve the application
• FDA plans to issue a CR letter with facility- or site-related deficiencies
• FDA plans to issue a CR letter without facility or site deficiencies
• FDA generally plans to defer action (i.e., miss the goal date) on an application

Further details can be found in the document.

How does FDA intend to prioritize inspections as travel restrictions are eased or lifted?

A risk-based approach will be used to prioritize the inspections. This can include:

• Impact of product availability to public health
• Safety of the investigator
• Location of the site and associated travel restrictions

FDA also notes that applications can still be submitted if facilities in regions that are impacted by COVID-19-related travel restrictions are included.