Pharmaceutical companies seeking approval from regulatory agencies such as the US Food & Drug Administration (FDA) or Japanese Pharmaceuticals and Medical Devices Agency (PMDA) to sell their drugs on the market must submit evidence to prove that their drug is safe and effective for its intended use. A team of physicians, statisticians, chemists, pharmacologists, and other clinical scientists review the clinical trial submission data and proposed labeling. If the review establishes that the there is sufficient statistical evidence to prove that the health benefits of the drug outweigh the risks, the drug is approved for sale.
The clinical trial submission package consists of tabulated data, analysis data, trial metadata, and statistical reports consisting of statistical tables, listings, and figures. In the case of the US FDA, the electronic common technical document (eCTD) is the standard format for submitting applications, amendments, supplements, and reports to the FDA’s Center for Biologics Evaluation

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