The FDA removed previously issued draft guidance on diversity in clinical trials from its website without public notice or ...

FDA Restructures its Food Resources Although there were a number of significant new regulations, the most significant food ...

On January 7, 2025, FDA published a draft guidance titled “Artificial Intelligence ... with study design details and statistical analysis plans. The study results should include adequate ...

The FDA announced its draft ... The recently published draft guidance recommends the use of controlled desaturation laboratory studies for device analysis but also states that real-world data ...

In the final days of the Biden Administration, the United States Food and Drug Administration (FDA) issued final guidance on ...

The Food and Drug Administration has determined that it is necessary for manufacturers of cat and dog foods who are covered by the FDA Food Safety Modernization Act Preventive Controls for Animal ...

The FDA closed the comment period for the draft Guidance on June 24, 2013 and is actively reviewing the submissions by numerous groups, including PhRMA. There is currently no set deadline by which ...

The FDA has released draft guidance with recommendations on tissue biopsies in ... The FDA noted that the statistical analysis plan of a trial should clearly outline how biopsy results will be ...

A new federal report on alcohol’s health effects has found even moderate drinking — within the bounds of U.S. nutrition guidance ... in environmental hazard laws is 1 in a million lifetime ...

The following is a message from the Director of the FDA Oncology Center of Excellence ... in the SOC arm (hazard ratio 0.48 [95% CI: 0.3, 0.78] 2-sided p-value 0.005). The final analysis of OS was not ...