Alzheimer’s disease remains one of medicine’s toughest challenges, affecting millions and costing trillions of dollars ...

Johnson & Johnson JNJ announced that it has submitted a new drug application (NDA) to the FDA seeking approval for its ...

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

Scientists at UCSF and Gladstone Institutes have identified cancer drugs that promise to reverse the changes that occur in ...

The FDA has not yet withdrawn the drug's approval, ...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.

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 ...

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

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.

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 ...

FDA's long-standing accelerated approval program generally issues decisions in six months for drugs that treat life-threatening diseases. Regular drug reviews take about 10 months.

Last week, the U.S. Food and Drug Administration (FDA) finalized guidance on the types of information that should be included in a Predetermined Change Control Plan (PCCP) as part of a marketing ...