Be statistically valid, reliable, and accurate, Be comparable across collection types; and Meet the minimum reliability threshold, as determined by statistical testing.

I. INTRODUCTION This guideline is intended to assist an applicant in presenting the clinical and statistical data required as part of an application under 21 CFR 314. 50. The guideline describes an …

The more alcohol consumed, the greater the risk of cancer. 6,8-11 For certain cancers, like breast, mouth, and throat cancers, evidence shows that this risk may start to increase around one or fewer …

Dec 22, 2025 · After reviewing scientific studies, the HHS Food and Drug Administration (FDA) determined in 1981 that aspartame was safe for use in foods. In 1987, the General Accounting Office …

Statistical sampling draws a random sample from a collection of claims and extrapolates (in other words, projects) the results of the sample to the entire “universe” of claims. OMHA statistical sampling is …

In principle, being able to detect a statistically significant difference in pairwise comparisons between doses is not necessary if a statistically significant trend (upward slope) across doses can be …

The national burden reflects de-duplicated infection and death estimates. Clostridioides difficile is related to antibiotic use and antibiotic resistance. It caused 223 thousand 900 cases and 12 thousand 800 …

Nov 10, 2025 · Women have used HRT products for decades to relieve menopausal symptoms. However, their use plummeted in the early 2000s when the FDA applied boxed warnings following a …

The ALJ erred as a matter of law in determining the sample was not statistically valid solely because the same random number seed was used to select samples in both strata and reserves.

This guidance is intended to describe some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identify some common inappropriate practices.