Saturday, December 27, 2008

Phase 1 Clinical Safety Data - How to Submit to FDA?

From the desk of Dante.

During negotiations with FDA, now preparing for submission activities - did you ever get a letter from FDA, pertaining to your safety data and asking for "some" pooling of safety data across all Phase 1 studies? In other words, a Phase 1 global integrated safety database?

Shocking isn't it?!

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