Clean Sweep Live Auction on Wed. May 1st. Click to view the full inventory

DOTmed Home MRI Oncology Ultrasound Molecular Imaging X-Ray Cardiology Health IT Business Affairs
News Home Parts & Service Operating Room CT Women's Health Proton Therapy Endoscopy HTMs Pediatrics
Current Location:
> This Story

Log in or Register to rate this News Story
Forward Printable StoryPrint Comment




U.S. Healthcare Homepage

Rural hospitals require better 'end of support' equipment solutions Sometimes replacing equipment is simply not an option

Peeling back the Medicare Advantage onion Understanding the high growth rate of MA plan coverage

FDA finds duodenoscope contamination risk still too high Up to 5.4 percent of properly collected samples has 'high concern' organisms

Fivefold difference found in Medicaid reimbursements for radiotherapy May limit access to healthcare, especially in rural areas

First ultra high-res CT scan performed on US patient Scanner at UC Davis can image anatomy as small as 150 microns

Joint Commission fluoro mandate may confuse providers, say experts Requires max exposure rates of imaging modes for fluroscopy devices

CMS to add more telehealth benefits to Medicare Advantage plans Aiming for greater flexibility, lower costs

Feds indict 24 in $1.2 billion healthcare fraud scheme DoJ says 'one of the largest healthcare fraud schemes' ever

House to evaluate bill on radiologist assistant service claims Calls for Medicare to accept claims of services performed by radiologist assistants

Radiologist compensation holds steady, female physicians closing pay gap Doximity study drew from self-reported compensation surveys

Scott Gottlieb courtesy of FDA

FDA commissioner Scott Gottlieb is resigning

by Thomas Dworetzky , Contributing Reporter
In the midst of his fight against teen vaping, which he attacked as “epidemic,” U.S. Food and Drug Administration (FDA) Commissioner Scott Gottlieb has resigned after less than two years at the helm.

In a letter, addressed to Secretary of Health and Human Services Alex M. Azar, he resigned, effective in one month.

Story Continues Below Advertisement

RaySafe helps you avoid unnecessary radiation

RaySafe solutions are designed to minimize the need for user interaction, bringing unprecedented simplicity & usability to the X-ray room. We're committed to establishing a radiation safety culture wherever technicians & medical staff encounter radiation.

Gottlieb leaves in the midst of the teen vaping battle and the opioid crises.

He noted what he considered to be a number of FDA achievements during his tenure, including new policies “to reduce the morbidity associated with tobacco use; to confront teen use of e-cigarettes; to decrease the rate of new opioid addiction; to improve access to affordable generic drugs; to modernize the development process for novel medical technologies like gene therapy and targeted medicines; to implement measures to improve food safety and our ability to identify and track outbreaks of foodborne illness; and to reduce the burden of chronic disease through better information and diets.”

He noted that “a record number of generic medicines, novel drugs, and novel devices” had been approved in 2017 – and that FDA beat that record in 2018. He stressed that FDA “set in motion a historic modernization” of both the Office of New Drugs and of the Office of the Commissioner.

In addition, the agency furthered “new approaches for the modern and efficient regulation of cell based regenerative medicine, complex generics, targeted cancer drugs, dietary supplements, digital health tools, and personal genetic tests,” he added.

Beyond that, new pathways for novel devices were created, including “modernizations of the 510(k) process,” he said. These would let device makers use the less demanding practice of comparing a new device to older ones on the market if they can show that it's “at least as safe and effective" as one that was already approved, according to numerous reports, including by HCB News in December, 2018.

"What we want to do is constantly push the market toward incorporating better technology and better capabilities by advancing the predicates and always looking forward so the ... predicates the device companies are using as the basis of their approvals are constantly incorporating newer and better technology to make the devices better and safer," Gottlieb said in an interview at the time with CNBC's Becky Quick.

He also highlighted the FDA's enforcement arm, which confronted “bad actors that put Americans at risk.” The agency “cracked down on bogus stem cell therapies, on sham homeopathy, on unsafe medical device products, on tobacco sales to minors, on unsafe dietary supplements, and on kratom.”
  Pages: 1 - 2 - 3 >>

U.S. Healthcare Homepage

You Must Be Logged In To Post A Comment

Increase Your
Brand Awareness
Auctions + Private Sales
Get The
Best Price
Buy Equipment/Parts
Find The
Lowest Price
Daily News
Read The
Latest News
Browse All
DOTmed Users
Ethics on DOTmed
View Our
Ethics Program
Gold Parts Vendor Program
Receive PH
Gold Service Dealer Program
Receive RFP/PS
Healthcare Providers
See all
HCP Tools
A Job
Parts Hunter +EasyPay
Get Parts
Recently Certified
View Recently
Certified Users
Recently Rated
View Recently
Certified Users
Rental Central
Rent Equipment
For Less
Sell Equipment/Parts
Get The
Most Money
Service Technicians Forum
Find Help
And Advice
Simple RFP
Get Equipment
Virtual Trade Show
Find Service
For Equipment
Access and use of this site is subject to the terms and conditions of our LEGAL NOTICE & PRIVACY NOTICE
Property of and Proprietary to DOTmed.com, Inc. Copyright ©2001-2019 DOTmed.com, Inc.