We’ve launched a first-of-its-kind app to help you find out where your generic drugs come from and see the track records of ...

Industry consultant Michael Drues will discuss how medical device companies can better prepare for FDA inspections.

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 ...

The repeat problems at Houston-based Empower Pharmacy include inadequate quality testing and a failure to clean equipment.

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, ...

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 ...

MedPharm’s topical drug product manufacturing facility in Durham has successfully completed an FDA inspection for commercial manufacture of drug products.

Some staff members say they are frustrated with the direction of inspections under new FDA Commissioner Dr Marty Makary. HealthDay News — The official in charge of federal food and drug safety ...

The FDA has made additional reports on inspections of ByHeart infant formula plants available. The company’s formula has been determined to be the source of at least 37 cases of infant botulism. The ...

The FDA is stepping up its unannounced inspections of foreign manufacturing facilities. In a statement about the increase in inspections, the Food and Drug Administration did not report how many ...

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 ...