Meryl Dersarkissian · FDA Watch · The Rise of Real-World Evidence in Regulatory Strategy, Part 3: RWE in Accelerated Approvals
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Conduct robustness checks by pre-specifying sensitivity, subgroup, and alternative analyses to show results are not dependent on a single assumption
“When you put together the code of conduct, if you run it through AI and to check for the perspective of a neurodivergent individual, it gives you feedback as to how does your code of conduct align to that”
“Taxonomy is the unglamorous foundation… one of the most successful and robust supply chains we have as a direct result of that.”
“Create weekly accountability check-ins that are focused on results.”
“Approach your forecast… by product… laid out as clearly as possible with assumptions and then showing that as evidence to an auditor”
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