Replies to post #28986 on Rivulet Media Inc (fka RIVU)

[Skelly22]

If no word from the FDA by then it can be assumed approved. After filing the FDA has 30 days to respond.


"Once the IND is submitted, the sponsor must wait 30 calendar days before initiating any clinical trials. During this time, FDA has an opportunity to review the IND for safety to assure that research subjects will not be subjected to unreasonable risk."

http://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/approvalapplications/investigationalnewdrugindapplication/default.htm

[DarkKnight83]

FDA update!

[psk3091]

In 24 days the IND, which was filed with the FDA on 2/5/13 will automatically be approved, unless the FDA disapproves it before that time. Of course, the FDA can also approve it at any time within 30 days of filing! :)

[psk3091]

In 24 days the IND, which was filed with the FDA on 2/5/13 will automatically be approved, unless the FDA disapproves it before that time. Of course, the FDA can also approve it at any time within 30 days of filing! :)