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

 
• By Derrick Gingery

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.

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

More from User Fees

More from Pathways & Standards