One of the concerns people have when they hear FDA is using AI in the drug approval process is that many people don't have a ...

Beyond staff cuts, the departures of some longtime investigators in recent months have left less experienced people tasked ...

From July 20-25, don’t miss these standouts — from donut holes to vegan bowls, and West African to Italian fare — off ...

Thailand's FDA intensifies its crackdown on illegal cannabis products with stricter inspections and prosecutions.

The FDA has introduced Elsa, an internal AI tool to review safety data, identify labeling issues, and prioritize inspections, ...

The U.S. Food and Drug Administration (FDA) has upgraded a recall of tomatoes sold in three southern states to a Class I recall, the most serious level, because the tomatoes may be contaminated ...

FDA Commissioner Dr. Marty Makary is leading a handful of controversial new initiatives to make the drug review process more ...

The FDA’s clunky launch of Elsa, an AI tool to increase efficiency, has sparked concern from agency employees and outside ...

A food recall of nearly 6,000 cases of cookies distributed across 15 states has been given the U.S. Food and Drug Administration's (FDA) second-highest risk level. Carley's Inc. voluntarily ...

Specifically, the new warning lists the risk of myocarditis as 8 cases per 1 million people who got the 2023-2024 COVID shots between the ages of 6 months and 64 years old. The label also notes that ...

The FDA has approved its requested updated versions of expanded warning labels for COVID-19 vaccines. As Healio previously reported, the FDA sent letters to Moderna and Pfizer/BioNTech in April ...