Policy initiatives have come fast and furious at the FDA this year. While guidances on rare diseases and vaccines have consumed most of the ink, policy shifts aimed at improving FDA efficiencies and ...

The U.S. FDA’s final guidance for clinical trial inspections conducted under the bioresearch monitoring (BiMo) program seems to deviate little if at all from the 2024 draft, but that is precisely the ...

AstraZeneca's MFN pricing agreement with the US government reflects broader efforts to reduce drug prices and enhance ...

The Food and Drug Administration is reportedly planning to end most of its routine food safety inspections. That’s a move that raises questions about the future of food safety across the U.S. and ...

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 ...

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 ...

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 ...

While the FDA’s inspection figures for drug manufacturing facilities have yet to fully recover from the COVID-19 pandemic, sweeping staff cuts have raised questions about how the agency plans to ...