Raw Data for a NDA submission

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Julzee
Julzee's picture
Raw Data for a NDA submission

Just wondering if anyone know what raw data should be included in final reports to be included in an NDA submission. Specifically, we use a plate reader and it pumps out its results which we plug in to excel, however, as the plate reader software calculates various things for us, not all the original well results are included in the excel file. WOuld that mean we have to include the print outs from the plate reader?

thuyha
thuyha's picture
Normally, you do not have to

Normally, you do not have to submit raw data just final results to the FDA. However, you may be asked to furnished the raw data to support the results.