On January 21, the US Food and Drug Administration (FDA) issued a draft guidance clarifying the agency’s authority to access ...

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

In its effort to play catch up after thousands of factory inspections were delayed during the coronavirus pandemic, the FDA is still lagging woefully behind and is unable to approach its pre-COVID ...

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 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 ...

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 ...

Amid concerns about FDA’s capacity to meet safety mandates following the departure of 3,500 employee since January, the agency signals a new direction for inspections and ability to do more with less ...

WASHINGTON (AP) — 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 ...