This is a rather loaded question so I am going to focus only on the clinical side of a submission. There are several factors that can come into play: rolling submissions, expedited review etc.. All studies should have the final design and statistical design submitted and only agreed upon changes to analysis (perhaps from end of phase meetings) finalized. The FDA review clock is available in guidances depending on what the submission is (expedited, etc). I'll let others add more detail.
------------------------------
Sarah Parsons RAC
Director Regulatory Affairs, Diagnostics
------------------------------
Original Message:
Sent: 24-May-2022 08:36
From: Yuwei Zhang
Subject: Times from registering studies to approvals
I am new and want to learn from you the big picture, from registering studies to final approval. Can anybody please let me know the timeline for registering studies and results from submissions and support by HAs? Should endpoints and study designs be submitted and can't be altered? When FDA and other agencies review related submissions, what if the study design has been changed? Should sponsors submit studies again?
------------------------------
Yuwei Zhang
Waltham MA
United States
------------------------------