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Re: HyGro post# 566380

Thursday, 02/09/2023 2:16:43 PM

Thursday, February 09, 2023 2:16:43 PM

Post# of 690223
That's simply their guidance when using patient level data, and not when using summary-level data. The FDA made that clear on page 2 of their guidance.

"Guidance" also being a key word here... this is not a "Directive."

Advice or information aimed at resolving a problem or difficulty, especially as given by someone in authority.
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