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 …
Alcohol and Cancer Risk 2024 - HHS.gov
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 …
Sexually Transmitted Infections (STIs) - HHS.gov
May 12, 2025 · In the United States, recent data show that rates of sexually transmitted infections (STIs) reached an all-time high in 2021 among both females and males, and all racial and …
Tobacco referenced in this fact sheet refers to commercial tobacco products and not to the sacred and traditional tobacco used by some American Indian communities for ceremonial or …
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 …
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 …
Opioid Facts and Statistics | HHS.gov
Dec 16, 2022 · HHS is deeply committed to improving the physical and mental health and well-being of every American as we work to address the evolving crisis. HHS continues to support …
HHS Advances Women’s Health, Removes Misleading FDA
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 …
The appropriate inquiry is whether there is a well-documented, statistically and clinically meaningful effect on a prospectively defined endpoint, not whether the endpoint was identified …