Keyword: Scott Gottlieb

Food and Drug Administration staffers were pleased to be back at work on Monday, Commissioner Scott Gottlieb said. 

Don Berwick, former CMS administrator and IHI co-founder, sat down with FierceHealthcare to discuss the state of health policy.

A group of recent FDA commissioners from both sides of the aisle agree: the agency should break up with the Department of Health and Human Services. 

The FDA has released model 1.0 of the Software Precertification Pilot Program to give guidance to the health IT community about AI.

FDA chief Scott Gottlieb, M.D., says he's staying at the agency as a reporter investigates rumors of his exit, plus more healthcare headlines.

With e-cigarette use doubling among high school seniors, the U.S. surgeon general issued a rare advisory warning about the health risk to kids.

The FDA plans to implement new changes to the 510(k) approval process, paving the way for a new generation of medical devices.

An expert task force has recommended that clinicians screen all women of reproductive age for intimate partner violence and more practice news.

The FDA will hold a two-day public meeting in December, asking external advisers to consider various options for increased naloxone availability.

The FDA plans to release new guidance on opioid prescribing, which it intends to use as the basis of new digital tools aimed at the epidemic.