In life sciences manufacturing, inspections by the FDA, state regulators or other agencies are part of the job. But too often ...

The Food and Drug Administration is developing a plan to shift more food safety inspection responsibility to state agencies over the course of five years, according to two sources familiar with ...

After a quiet January marked by administrative transition and internal upheaval at FDA, enforcement activity has accelerated sharply in 2025. No warning letters were issued in the first month of the ...

Government shutdowns lead to decreased predictability, causing delays in new submissions and manufacturing changes. Key risk ...

On May 6, 2025, the U.S. Food and Drug Administration (FDA) announced a plan to expand its use of unannounced inspections of foreign manufacturing facilities that produce foods, essential medicines ...

Cuts at the FDA are slowing inspections of overseas drug manufacturers, prompting concerns from former and current employees that medication safety could be at risk, ProPublica reported July 7. Dozens ...

With every bottle of prescription medication comes an implied promise: The drugs are safe and effective and meet strict standards set by the Food and Drug Administration. But the agency known as one ...

Patients hoping to get their hands on a cheaper copycat of Johnson & Johnson’s fading anti-inflammatory blockbuster Simponi may have to wait for a few months more, thanks to an FDA inspection this ...

Cheerios and Nutella among products pulled.

A major FDA recall of everyday products across the Midwest is tied to possible contamination with rodent urine and feces.