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Posted On: 07/15/2020 6:40:10 PM
Post# of 148949
Ohm20
The Fda can’t review what it doesn’t have. Our company failed to take full advantage of rolling review.
Despite stability data (the only thing they were supposed to be waiting for) being done in 2019, we didn’t even file that section until late April of 2020. In my experience you can filled with limited stability data with the commitment to communicate the results of future timepoints to set the final shelf life of the product. Do you have different experience we than that’s?
To put this solely on the FDA does not represent a fair allocation of blame.
IMO
The Fda can’t review what it doesn’t have. Our company failed to take full advantage of rolling review.
Despite stability data (the only thing they were supposed to be waiting for) being done in 2019, we didn’t even file that section until late April of 2020. In my experience you can filled with limited stability data with the commitment to communicate the results of future timepoints to set the final shelf life of the product. Do you have different experience we than that’s?
To put this solely on the FDA does not represent a fair allocation of blame.
IMO
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