The U.S. Food and Drug Administration (FDA) recently issued final guidance entitled “Conducting Remote Regulatory Assessments,” which explains the agency's plans to continue utilizing its records ...

FDA recently issued the draft guidance, Quality Management System Information for Certain Premarket Submission Reviews. The guidance is designed to prepare industry for the February 2, 2026 effective ...

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 ...

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 ...

An FDA investigator prepares a test sample for IMS analysis from a shipment of dietary supplements that arrived at the Port of Buffalo in Buffalo, N.Y. (FDA photo) The outbreak of COVID-19 has called ...

In response to a report from the Government Accountability Office, the FDA says the biggest stumbling block to conducting inspections of food facilities is understaffing. The Food and Drug ...

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 ...

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 ...