FDA Clarifies Actions it May Take on Applications When it Can’t Inspect

In a revised guidance that will stay in effect until the end of the pandemic, the FDA explained how it will deal with drug applications when it is unable to conduct an inspection because of travel restrictions.

The agency plans to continue using alternative assessment tools to approve a new application, issue a complete response letter or defer an action when it can’t conduct an inspection, according to the guidance released yesterday. Alternate tools include relying on inspection reports from global regulators, conducting remote records reviews and carrying out virtual inspections using live or recorded video (DID, April 15).

The FDA said it will approve a drug application if the alternate tools show the manufacturing facility is compliant, the application satisfies all requirements for approval and “no other deficiencies have been identified.” The sponsor may also use these tools to respond to any FDA-defined problems in an application, potentially waiving the need for an inspection, the agency said.

If the FDA plans to issue a complete response letter to a facility for deficiencies, and alternative tools are unable to address these issues, the agency will inform the sponsor as soon as possible that an inspection is needed before the application can be approved.

The agency may issue a complete response letter without finding manufacturing site deficiencies because the application contains insufficient information to determine whether the facility is acceptable. In these cases, the FDA won’t include a facility deficiency in its letter, if it is unable to conduct an inspection by the target approval action date due to travel restrictions.

Instead, the guidance says, the complete response letter “will list the other deficiencies” and also include a comment noting that an inspection will be necessary to support approval of the application “because there is insufficient information available to make a determination on the acceptability of a facility.” In these instances, the agency stated it will inform sponsors that an inspection won’t be conducted before the target action date due to travel restrictions.

The FDA said it expects to defer action in most cases, such as missing a target action date for a drug application review, if an inspection is necessary because an application features insufficient information for the agency to make an approval determination.

Read the FDA guidance here: www.fdanews.com/05-17-21-COVID19QA.pdf. ― Jason Scott