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Gottlieb's Confirmation: Will Industry Ties Remain A Problem After The Hearing?

 
• By Derrick Gingery

The US FDA commissioner does not generally get involved with day-to-day activities, former FDA chiefs say, but perception of bias could be a lasting problem.

Scott Gottlieb's industry ties are likely to be a focus of his April 5 Senate confirmation hearing to be US FDA commissioner, but they seem unlikely derail his confirmation, and even the recusals he'll take once he joins the agency probably won't have much of an impact on his activities. However, the perception of potential bias could create a public relations problem, especially if widespread belief that FDA is unduly relaxing its regulatory requirements surfaces.

In interviews, several former senior FDA officials said that, in practice, Gottlieb will rarely run into a situation where he...

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More from Policy & Regulation

EUDAMED Notice Anticipated By September As Commission Optimizes Operations

 
• By Amanda Maxwell

The last steps are taking place leading to the launch of the EU’s medical device database, EUDAMED.

From Imitation To Action: Johns Hopkins Robot Autonomously Performs Key Step In Gallbladder Surgery

 
• By Marion Webb

Researchers at Johns Hopkins have used a robotic system to autonomously perform a key part of gallbladder surgery without a surgeon's hand. Lead author Axel Krieger says it could take five to 10 years before an autonomous robotic system will reach human trials and expects regulatory hurdles.

Remote Regulatory Assessments Become Swiss Army Knife For US FDA’s Oversight Of Facilities

 
• By Malcolm Spicer

“RRAs are valuable oversight tools and under certain circumstances, can assist FDA in its mission to protect public health, oversee regulated industry, and help ensure regulated products comply with FDA requirements,” according to final guidance.