Novo Nordisk's reports to the FDA spiked shortly after an inspection found the Ozempic producer ignored reports of deaths and potential side effects.

The agency’s lengthy “Human Foods Program 2026 Priority Deliverables” targets food dyes and other ingredients, the GRAS ...

Novo Nordisk issued a response to an FDA warning letter that cited serious violations in how the company tracked and reported ...

SK pharmteco today announced the successful conclusion of a regulatory inspection of its small molecule North America facility in La Porte, Texas. The U.S. Food and Drug Administration (FDA) carried ...

Simtra BioPharma Solutions was issued a warning letter by the FDA after an inspection uncovered a number of problems at the ...

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 ...

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 ...

After years of discussion, the Food and Drug Administration may shift responsibility for routine food safety inspection to the states. While industry and food safety experts say it's a logical move, ...

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 ...

Senior Food and Drug Administration leaders are planning for cutbacks to the number of routine food and drug inspections conducted by the agency, multiple officials say, due to steep layoffs this week ...

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 ...

As COVID-19 swept across the globe in early 2020, the Food and Drug Administration (FDA) pulled most of its safety inspectors from the field, creating a massive backlog of uninspected pharmaceutical ...