For both foods and drugs, most foreign inspections were pre-announced; the agency also re-emphasized its ban on inspectors ...

Company confirms high standards for data integrity and quality systems MINNEAPOLIS, MINNESOTA / ACCESS Newswire / May 20, ...

Food safety warning letters have stalled at the FDA after the agency temporarily laid off the staff who review them.

FDA inspections are essential to ensuring the safety and quality of products in the food, pharmaceutical, and medical device industries. One of the experienced professionals in this field is John ...

Integra LifeSciences Holdings Corp. brass oversold fixes to its manufacturing practices to meet Food and Drug Administration standards before it shared updates to its compliance improvement program, a ...

The FDA leadership is aiming not only to expand AI applications but also to refine the technology for usability, security, ...

FDA inspections are crucial for ensuring the safety, efficacy, and compliance of products in industries like pharmaceuticals, food, and medical devices. These inspections are conducted by ...

The agency issued a request for information on changes to minimum and maximum levels of certain nutrients and other new ...

Zhong Li’s extensive history with the FDA offers crucial lessons on how companies in the pharmaceutical and biopharmaceutical sectors should approach inspection preparedness.  As an experienced FDA ...

President Donald Trump signed a new executive order this week directing pharmaceutical companies to lower U.S. drug prices to match the costs paid by other countries—a dramatic-sounding move that ...