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SC8

06/01/22 12:30 PM

#147480 RE: Rusty nail #147479

You're confusing the outline of proposed testing with the detailed test plan. At May 20 meeting, FDA gave feedback on the outline and some initial guidance on what they expect in detailed test plan.

kayak_wench

06/01/22 3:14 PM

#147481 RE: Rusty nail #147479

During the meeting they discussed a detailed outline. They now have to write the detailed plan. Meaning they had the table of contents of the test plan done. Now they have to write the test plan document body.