If a study is disqualified under Subpart K, can other studies from the same facility be considered?

• A. They may be considered if submitted prior to the disqualification date
• B. They cannot be considered under any circumstances
• C. They are automatically approved
• D. They must be resubmitted with a new protocol

Answer: (A)

When a GLP facility is disqualified under Subpart K, that status applies to new submissions going forward—the regulator won’t rely on data from that facility for new studies after the disqualification date. However, studies from the same facility that were submitted before that date can still be considered, because the data were generated under GLP requirements prior to the disqualification. The critical point is the submission date relative to the disqualification date: anything submitted after the date is not eligible, even if the work was done at the same facility. So, other studies from the facility can be reviewed if their submissions occurred before the disqualification date.