Rivulet Media Inc (fka RIVU)

[dingo8mymoney]

III. YOUR SUBMISSION IS MAILED TO FDA – WHAT HAPPENS NEXT?


1. Applications received in Central Document Room are assigned to a Center and Project Manager

2. You will receive a ‘Letter of Acknowledgement’ with IND/IDE #, date of receipt, Project Manager contact information. The 30 day clock is ticking!

3. A group of experts will review your submission

4. The reviewers will comment and/or request changes to your proposal.
OR
You will receive a letter of ‘No Objections’ and may begin your study
OR
You will not receive any communication from FDA. After 30 days, you may begin the study.