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 ...

The U.S. Food and Drug Administration (FDA) has issued a draft guidance reminding the cosmetics industry that the agency can access a variety of business records ...

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 ...

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

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, ...

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 ...

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 ...

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 ...

WASHINGTON — The Food and Drug Administration (FDA) has fallen short of its facility inspection targets, according to the Food Safety: FDA Should Strengthen Inspection Efforts to Protect the US Food ...