THE IMPACT OF COVID-19 ON RANDOMIZED CLINICAL TRIALS
The COVID-19 pandemic has a major impact on the conduct of most on-going clinical trials, in particular on the treatment of patients and the schedule of their planned protocol visits. General guidance is available from both FDA and EMA on […]
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FDA Draft Guidance on Expansion Cohorts – Read IDDI Comments
FDA Draft Guidance on the Use of Expansion Cohorts in first-in-human clinical trials IDDI has submitted a comment on the Food and Drug Administration (FDA) recent Draft Guidance for Industry regarding the use of expansion cohorts in first-in-human clinical trials. With […]
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