Dr. Margaret Hamburg
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Plenty of IPO movements and Margaret Hamburg has a new job (Morning Read)
Aduro Biotech, InfaredX, OpGen and Carbylan Therapeutics all were talking IPO yesterday – some good news and some not so good news, depending on your point of view. Also, Margaret Hamburg’s got a new job. Read the summary of the last 24 hours in the business of healthcare with our Morning Read.
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Devices & Diagnostics, Startups
FDA Commissioner tackles medical device outsourcing to Europe – and gets a pointed rebuttal
Serious U.S. regulatory lags are driving the medical device business to Europe – with startups, clinical […]
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Do you advise self-insured employers? You Can Help Us!
Take part in this survey and share some of the trends you are seeing among your clients across healthcare, including chronic conditions, behavioral health and navigation.
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Devices & Diagnostics, Health IT, Hospitals, Policy
Want to be influential in healthcare? Still helps to be white, male and highly paid
So, it’s true. The top 2 spots in Modern Healthcare’s 2014 list of the 100 […]
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Devices & Diagnostics, Health IT, Hospitals, Policy, Startups
Will FDA step in with lab development tests?
In her speech at Advamed 2013, FDA Commissioner Dr. Margaret Hamburg said a new challenge […]
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Devices & Diagnostics, Hospitals, Pharma, Policy
“Austere” 2014 budget proposal for HHS seems to make everyone unhappy
President Barack Obama’s proposed 2014 budget includes an increase of $3.9 billion to implement the […]
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FDA Commissioner Hamburg: ‘We want to work with the 510(k) process’
Pharmaceutical and medical device companies have long grumbled about the U.S. Food and Drug Administration‘s […]
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FDA asks Congress for 33 percent budget increase
The federal watchdog agency is pitching Congress and President Barack Obama for $4.3 billion for fiscal 2012, about a third more than it got in 2010. The FDA’s fiscal 2011 request was for $4.03 billion, a 23 percent increase over 2010.
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Minnesota senators recruit buddies to pressure FDA over 510(k)
Minnesota Sens. Amy Klobuchar and Al Franken along with Rep. Erik Paulsen have championed the medical device industry, giving speech after speech and writing letter after letter to the Food and Drug Administration about upcoming changes to its 510(k) approval program. I doubted the campaign would do much. But Wednesday, a bipartisan group of 15 senators sent a letter to FDA Commissioner Dr. Margaret Hamburg urging her agency, among other things, to adopt a more deliberate, cautious approach to amending 510(k).
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Devices & Diagnostics, MedCity Influencers, Policy
FDA head: agency will hear concerns about 510k approval process
Dr. Margaret Hamburg looks to quell concerns about the Food & Drug Administration’s plan to […]
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Trayt Health Seeks to Increase Access to Diagnoses and Treatments
CEO Malekeh Amini explains how Trayt Health can bridge the gap for patients seeking neurological care.
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Klobuchar, Paulsen urge FDA not to quash Minnesota device industry
Minnesota’s medical device community has enlisted some big guns to lobby the Food and Drug […]