Table 2.

PSA timeline

Day	FDA	EMA
Anytime	Sponsor submits request for PSA to FDA and EMA Agencies decline no PSA Agencies accept Sponsor begins drafting meeting package according to SAWP procedures
Varies		Meeting Package Submission and Validation Phase; Option for preparatory meeting with EMA according to SAWP procedures
0	EMA validates meeting package; FDA receives validated meeting package; Procedure begins
15–25	FDA internal meeting	EMA SAWP internal discussion
30–34	FDA sends Preliminary Comments to EMA	EMA sends List of Issues to FDA
35	Bilateral FDA/EMA meeting
65	Trilateral Sponsor/FDA/EMA meeting
75 to 95	FDA issues final meeting minutes (30 days after trilateral)	EMA issues final advice letter (10 days after trilateral)