007: Quality Data For FDA Submissions With Dr. Robert Hariri
Business Of Biotech
00:00
How to Prepare for a First Time FDA Submission
The FDA is very diligent about the review of any materials that are submitted by a candidate company looking at developing a therapeutic. Varyi: There's no shortcut to giving them everything they need to make a decision and it's important also that you enter into these relationships as a partner if you will in the dialogue. The bar for getting to that level is high even in an emergency situation like covid-19, he says.
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