An analysis from the Congressional Budget Office warns that cuts to the National Institutes of Health and FDA drug reviews could significantly reduce the number of new medications reaching the U.S.

The standard threshold for approval in an FDA clinical trial is a false positive rate of 2.5 percent or less; in other words, the FDA is willing to tolerate approving ineffective drugs 2.5 percent ...

The Food and Drug Administration (FDA) can maintain its high bar for safety and efficacy, and also cut the waste and ...

FDA Commissioner Marty Makary, M.D., has made his pick for the next director of the FDA’s Center for Drug Evaluation and ...

The FDA approved a label update with a new titration schedule for donanemab (Kisunla), an anti-amyloid drug approved to treat ...

How FDA approval will change COVID-19 ... In its review for approval, the U.S. Food and Drug Administration analyzed clinical trial data from about 20,000 vaccine recipients and concluded ...

The FDA has not yet withdrawn the drug's approval, ... Changes to the accelerated approval process ultimately passed in the year-end omnibus spending bill that was signed into law on Dec. 29.

While we all value the fact that the FDA goes to great lengths to ensure the safety and efficacy of new drugs, the process can often drag on for over a decade, depriving people of live-saving drugs.

Obtaining FDA clearance or approval is just the beginning of a company’s regulatory journey. As FDA-regulated products evolve, changes to ...

The legislation was spurred by the fracas over the Alzheimer’s drug Aduhelm, which received a so-called accelerated approval. Nearly every member of an FDA advisory panel voted against approving ...