Our latest focus is trying to bring data to bear on common questions we get asked by clients. Last month the topic was: how well does my device need to perform to get premarket clearance from FDA? This month it is: how big does my sample size need to be for any necessary clinical trial for premarket clearance?
To date, our typical answer has been, it depends.[1] We then explain that it’s not really a regulatory question, but a question for a statistician that is driven by the design of the clinical trial. And the design of the clinical trial is driven by the question the clinical trial is trying ...
On September 20, 2018, the U.S. Food and Drug Administration (“FDA”) released draft guidance “Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank” (“Guidance”). The purpose of this Guidance is to explain FDA’s protocol in (1) determining how the centers will identify whether responsible parties failed to comply with submission and certification requirements to the ClinicalTrials.gov or submitted false or misleading documents to the data banks and (2) deciding when, why, and what civil monetary penalties will be assessed against the ...
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