Trump's pick for HHS secretary who endured confirmation hearings last week—has repeatedly criticized industry ties to the FDA ...

On January 7, 2025, the FDA issued a draft guidance called Considerations for the Use of Artificial Intelligence to Support Regulatory ...

The FDA released this guidance as part of the Center for Drug Evaluation and Research’s Framework for Regulatory Advanced ... response efforts involving in-process sampling given the vagueness ...

For example, the US Food and Drug Administration (FDA) and the European Medicines ... a critical factor in the accomplishment of the regulatory process. This implies that potential regulatory ...

A clinical trial comparing a one-page medication handout proposed by the U.S. Food and Drug Administration (FDA) with an ...

The FDA approved 16 psychiatric drugs over the last decade, most of which shared similar mechanisms of action with previously ...

The Food and Drug Administration has ignited a heated debate with its latest review of menthol cigarettes, revealing ...

Novo Nordisk said on Wednesday it plan to file its experimental next-generation obesity drug CagriSema for regulatory approval during the first quarter of next year, slightly later than its previous ...

Genentech Inc. won regulatory approval Tuesday to market an eye implant that can be refilled every six months with an already ...

The FDA has accepted for review the NDA for bumetanide nasal spray for edema associated with CHF, as well as hepatic and renal disease.