State and federal officials will now have unified federal standards guiding produce inspections under new guidelines being ...

On February 2, 2026, FDA’s new Quality Management System Regulation (“QMSR”) for medical devices became effective, two years after FDA’s issuance of a final rule to implement the QMSR. The QMSR ...

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, ...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety of business records ...

The FDA never inspected Johns Dental Laboratories during more than a decade in which it made the Anterior Growth Guidance Appliance, or "AGGA," a dental device that has allegedly harmed patients and ...

The FDA is considering reducing its routine food safety inspections and shifting more responsibility to state agencies. However, critics are concerned that this action could undermine oversight and ...

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 ...

Introduction to AuditsIn the fields of pharmaceuticals and medical devices where regulation is imposed, compliance with the quality standards set by the authorities is vital for the protection of the ...

The Food and Drug Administration is inspecting far fewer pharmaceutical companies conducting clinical research as it adjusts to the post-pandemic world and a smaller workforce, which an auditor warned ...

WASHINGTON -- Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the covid-19 pandemic upended factory ...

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 ...

A federal pullback could shift oversight responsibilities to the states, with consumer groups expressing concern that the move will slow responses to outbreaks. Stacey Leasca is an award-winning ...