The politics of innovation: Ideomed CEO offers perspective on mobile health regulation

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The politics of innovation: Ideomed CEO offers perspective on mobile health regulation

July 11, 2014 7:08 am by | 2 Comments

The shift in the U.S. Food and Drug Administration’s approach to regulating some mobile health applications is benefiting companies such as Ideomed. The 4-year old company’s app Abriiz helps users…


As the next wave of health apps blurs the line between clinical & consumer, can FDA keep up?

As the next wave of health apps blurs the line between clinical & consumer, can FDA keep up?

July 21, 2014 3:56 pm by | 0 Comments

The Food and Drug Administration (FDA), which regulates everything from heart monitors to horse vaccines, will increasingly have its hands full keeping its eye on consumer health apps and devices,…


An FDA “curriculum” helps guide medical device startups through regulatory maze

An FDA “curriculum” helps guide medical device startups through regulatory maze

July 18, 2014 12:01 pm by | 1 Comments

It’s  tough for medical device companies to get that stamp of FDA approval, but the labyrinthine regulatory pathway certainly doesn’t help things. Regulators want to change that: “…we learned that the delivery of…



FDA calls committee to discuss heart risks of testosterone replacement products

FDA calls committee to discuss heart risks of testosterone replacement products

July 17, 2014 3:28 pm by | 0 Comments

(Reuters) – The U.S. Food and Drug Administration has called an advisory committee meeting on Sept. 17, to discuss the adverse cardiovascular outcomes with the usage of testosterone replacement therapy….


FDA comes under fire for tobacco research grants awarded to advisory committee members

FDA comes under fire for tobacco research grants awarded to advisory committee members

July 11, 2014 4:10 pm by | 0 Comments

WASHINGTON (Reuters) – Last year the U.S. Food and Drug Administration recommended that millions of dollars in research grants be awarded to scientists serving on its tobacco advisory committee, even…


FDA investigating uterine fibroids procedure tied to spread of rare cancer

FDA investigating uterine fibroids procedure tied to spread of rare cancer

July 8, 2014 1:59 pm by | 0 Comments

(Reuters) – A uterine surgical technique that has been linked with the spread of a rare type of cancer poses a serious concern to regulators that will be addressed this…


For FDA, setting e-cigarette policy involves Facebook, tweens & $270M in research funding

For FDA, setting e-cigarette policy involves Facebook, tweens & $270M in research funding

July 7, 2014 9:11 am by | 0 Comments

NEW YORK (Reuters) – One team of researchers assessing the risks of electronic cigarettes is counting the puffs taken by volunteer “vapers.” Another will comb Facebook for posts on how…


23andMe and FDA find a way to work together in shifting political atmosphere

23andMe and FDA find a way to work together in shifting political atmosphere

June 28, 2014 11:00 am by | 0 Comments

Genetic testing company 23andMe and the Food and Drug Administration (FDA) have had a rocky relationship, to say the least. But seven months after the FDA barred 23andMe from predicting customers’…



White House tones down FDA’s proposed tobacco regulations

White House tones down FDA’s proposed tobacco regulations

June 25, 2014 10:30 am by | 0 Comments

WASHINGTON (Reuters) – White House changes to proposed rules for tobacco products significantly weakened language detailing health risks from cigars and deleted restrictions that might have prevented online sales of…


Hospitals in hot water over saline shortage, which could last through year’s end

Hospitals in hot water over saline shortage, which could last through year’s end

June 25, 2014 9:51 am by | 0 Comments

Hospitals across the country are struggling to deal with a shortage of one of their essential medical supplies. Manufacturers are rationing saline — a product used all over the hospital…


FDA staff report questions AstraZeneca’s experimental therapy for BRCA ovarian cancer

FDA staff report questions AstraZeneca’s experimental therapy for BRCA ovarian cancer

June 23, 2014 11:09 am by | 0 Comments

(Reuters) – Staff reviewers at the U.S. Food and Drug Administration said AstraZeneca Plc’s experimental ovarian cancer drug olaparib showed an 83 percent reduction in the risk of disease progression…


Pharmas off the hook for large heart safety trials of new opioid-induced constipation meds

Pharmas off the hook for large heart safety trials of new opioid-induced constipation meds

June 12, 2014 2:25 pm by | 0 Comments

WASHINGTON (Reuters) – An advisory committee to the U.S. Food and Drug Administration recommended on Thursday that the agency not require large cardiovascular safety trials for a class of drugs…


A small sigh of relief for Geron as FDA lifts partial clinical hold on trials of its only drug

A small sigh of relief for Geron as FDA lifts partial clinical hold on trials of its only drug

June 12, 2014 2:02 pm by | 0 Comments

(Reuters) – Geron Corp said the U.S. Food and Drug Administration had lifted a partial clinical hold on a study testing its sole drug as a treatment for myelofibrosis, a…


Shire agrees to FDA request for more trials of ADHD medicine in children

Shire agrees to FDA request for more trials of ADHD medicine in children

June 12, 2014 1:20 pm by | 0 Comments

LONDON (Reuters) – London-listed drugmaker Shire PLC said it had agreed to a request from the U.S. regulator to test the use of its amphetamine-based drug Vyvanse in preschool children…


FDA ‘seriously considering’ all public comments in shaping e-cigarette regulations, standards

FDA ‘seriously considering’ all public comments in shaping e-cigarette regulations, standards

June 12, 2014 9:06 am by | 0 Comments

WASHINGTON (Reuters) – The U.S. Food and Drug Administration is working to develop strong product standards for electronic cigarettes and other nicotine delivery devices that will protect public health and…


Orexigen will have to wait 3 more months for FDA’s decision on Contrave weight loss pill

Orexigen will have to wait 3 more months for FDA’s decision on Contrave weight loss pill

June 11, 2014 11:44 am by | 0 Comments

(Reuters) – Orexigen Therapeutics Inc said the U.S. Food and Drug Administration delayed a decision on the marketing application for its obesity drug, contrave, by three months, sending the company’s…