Profile

Dear community, For IND, does the sponsor needs to write anything in M 3.2.P.8.2 Post-approval Stability Protocol and Stability Commitment?  Thank you. ------------------------------ Hua Jin United States ------------------------------

Hello all, For phase I IND submission to the FDA, should one check box B or box C for the 3674 form section 9. Box A is checked if the clinical trial is not subject to the registration requirements Box B is checked if the registration requirements do not apply at the time of the submission of the ...

Thank you very much to all of you who took the time to answer my question. ------------------------------ Hua Jin Woodridge IL United States ------------------------------

Hello Dan, I did not make it clear. I try to put a range on the actual pulling date.  For 1 M samples: Duration 30 days Allowed Actual Pulling date: Expected pulling date +/- 1 day For example, if the expected pull date for 1M sample is 6/29/22, the actual pulling date can be any day between ...

Thank you Dan for your quick reply! How about the ranges?  Does the following make sense? 1 month: +/- 1 day >= 3 months +/- 7 days >= 1 year +/- 10 days Thank you! ------------------------------ Hua Jin Woodridge IL United States ------------------------------