Keyword: Scott Gottlieb

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. 

FDA Commissioner Scott Gottlieb said manufacturers must address cybersecurity from the design phase through the device’s time on the market.

Three senators are concerned about the FDA's Pre-Cert program. VA and DOD leaders pledge accountability on EHR modernization.

A massive package of legislation aimed at addressing the nation's opioid addiction crisis is heading to the president's desk and other healthcare headlines from around the web.

FDA Commissioner Scott Gottlieb said the agency will recommend that manufacturers include a "bill of materials" to help hospitals manage cyberattacks.

While well-intentioned, the law could create opportunities for hucksters and snake-oil salesmen to prey on those who are vulnerable.

Scott Gottlieb voiced his support for changing business models to one he believes would better incentivize companies to create new antibiotics.