A PDUFA First: Pre-Approval Inspection Notice Goal Will Be Created

Under new user fee agreement, sponsors will get at least 60-day notice when a pre-approval inspection is necessary; regulators and manufacturers hope increased communications will lead to more efficient reviews.

The PDUFA VII agreement will increase inspection communications between the FDA and manufacturers. • Source: Alamy

The US Food and Drug Administration is standardizing its approach to alerting applicants about site inspections during the upcoming prescription drug user fee cycle, the first time such a manufacturing provision has been included in the agreement.

When the FDA determines that a pre-approval or pre-licensure inspection will be necessary, the PDUFA VII commitment letter states...