Sponsors should evaluate a suspected adverse react
Post# of 148179
(Total Views: 730)
Posted On: 07/01/2020 1:41:36 PM
Quote:
Sponsors should evaluate a suspected adverse reaction in the context of other related reports or adverse events, including those that occurred in the placebo or active comparator group and those that occurred in pre- and postmarketing studies.
https://www.fda.gov/media/79394/download
Have you ever looked at released data from any trials with placebo arms?
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