Loss of support staff has slowed critical investigations of drug manufacturers. Little relief has materialized.

The investigative unit, which looks into potential safety issues with drugs, vaccines, medical devices, and other products, has had a retention problem for years. Inspectors leave so often that, even ...

Around 3,500 FDA employees received termination emails; FDA Commissioner Marty Makary suggests lowering industry user fees ...

Sarepta Therapeutics lays off 493 workers amid FDA probe, stock drop, and concerns over its gene therapy treatment, Elevidys.

The U.S. Food and Drug Administration is planning to ask Sarepta Therapeutics to voluntarily stop all shipments of its gene ...

In the first 6 months of 2025, 385 employees resigned from the Center for Drug Evaluation and Research, compared with under ...

U.S. regulators asked Sarepta Therapeutics on Friday to voluntarily halt shipments of its Elevidys gene therapy after a ...

In last week’s Supreme Court ruling, the justices allowed federal agencies to proceed with their reduction-in-force, or RIF, ...

Although Sarepta initially appeared to have avoided the worst possible outcome for Elevidys—market withdrawal—thanks to the gene therapy’s new black box warning, the FDA is signaling stronger ...

Marcel Botha discusses whether AI can truly be used to replace laid off human workers at FDA.

HHS faces other legal challenges over its workforce cuts. A class-action lawsuit in the U.S. Court for the District of Columbia claims the department relied on “hopelessly error-ridden” data when it ...

Unlike Drs. Adam Cifu and John Mandrola, I do not constantly boast of my "nuance" or claim to be a master of "clinical ...