The FDA encourages sponsors to discuss plans to use animal testing alternatives, called new approach methodologies or NAMs, ...

The U.S. Food and Drug Administration on Tuesday issued new draft guidance on reducing the use of lab monkeys in preclinical ...

FDA inspection documents reveal systemic contamination issues at ByHeart formula plant as botulism outbreak sickens 37 ...

The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...

The Food and Drug Administration ("FDA") recently issued revised draft guidance on remote regulatory assessments ("RRAs")—voluntary or mandatory examinations of food, drug, device, and tobacco ...

The FDA's removal of draft guidance on clinical trial diversity raises concerns about its commitment to diversity and compliance with statutory obligations. The draft guidance aimed to improve the ...

The drive to roll out AI comes after sweeping job losses at the FDA that resulted from the cost-cutting drive implemented by ...

In the past, FDA handled all inspections of manufacturing facilities. However, as U.S. manufacturers began to expand nationally and globally, the rising rate made it difficult for the limited number ...