As part of the animal drug application, supplemental animal drug application, or investigational animal drug submissions, CVM is requesting early communication from sponsors of anticipated submissions for foreign manufacturing facilities. Participation by sponsors is voluntary.
The information submitted regarding foreign pre-approval inspections (PAIs) will help FDA predict and manage facility inspections.
The Agency will keep a record of the number of foreign PAIs conducted for new animal drug applications, along with the average time for completing the PAIs, and include this information in its annual performance report.
On an annual basis, sponsors should determine foreign facilities involved in Chemistry Manufacturing and Controls (CMC) Sections or prior-approval supplements and submit the information to a General Correspondence file.
If you have any questions please contact: Robin Stone, firstname.lastname@example.org, (240) 402-0678.