Congress failed to pass a budget so the federal government shutdown started today. The lapse in funding affects many health programs from the research at National Institutes of Health to enrollment in clinical trials to the Women, Infants and Children nutritional program. The Washington Post has a detailed list of who went home this morning […]
Crowdfunding isn’t just for raising money, at least in the eyes of digital health company Scanadu. The startup, which is vying for the $10 million Qualcomm Tricorder XPRIZE with its medical scanner, brought in some $1.2 million through crowdfunding platform indiegogo earlier this year. But it also did something interesting that might become more common […]
Gabby Everett, the site director for BioLabs Pegasus Park, offered a tour of the space and shared some examples of why early-stage life science companies should choose North Texas.
LONDON (Reuters) - GlaxoSmithKline has filed for U.S. approval of a two-drug combination against melanoma earlier than many industry analysts expected, using data from a mid-stage clinical trial. The move highlights a growing belief among drug companie...
Lately, the U.S. Food and Drug Administration seems to be doing a bit of re-branding: A new Patient Network site is anchoring a push for more patient engagement in the agency’s decision-making duties. There’s a good reason for that move, and it’s not just because everybody else is doing it. “There’s this transition in thinking […]
Version 2.0 of a plan to create an Office of mHealth in the U.S. Food and Drug Administration should be out soon. The office of U.S. Rep. Mike Honda, Silicon Valley’s Democratic Congressman who authored the legislation, said the next draft will at the least fine-tune the way the office would work with other federal […]
(Reuters) - The U.S. Food and Drug Administration said on Friday that fraudulent versions of the wrinkle treatment Botox, which is made by Allergan Inc and also used to treat headaches, underarm sweating and overactive bladder, are being sold in the Un...
A specialty drug is a class of prescription medications used to treat complex, chronic or rare medical conditions. Although this classification was originally intended to define the treatment of rare, also termed “orphan” diseases, affecting fewer than 200,000 people in the US, more recently, specialty drugs have emerged as the cornerstone of treatment for chronic and complex diseases such as cancer, autoimmune conditions, diabetes, hepatitis C, and HIV/AIDS.
As part of its effort to be more transparent and loop patients into its processes and policies, the U.S. Food and Drug Administration this week launched a new website called FDA Patient Network. It’s meant to be an educational resource for patients, patient advocates and consumers to learn about drug and device approval, off-label use […]
President Barack Obama’s proposed 2014 budget includes an increase of $3.9 billion to implement the Affordable Care Act, with $1.5 billion of that going to support the launch of health insurance exchanges. Health and Human Services Secretary Kathleen Sebelius said that this figure would cover both outreach to support enrollment and building the federal exchange. […]
NEW YORK (Reuters) - A federal judge on Friday ordered the Food and Drug Administration to make the "morning-after" emergency contraception pill available to girls of all ages without a prescription. The ruling by U.S. District Judge Edward Korman in B...
If this is the way most House hearings go, I can see why nothing gets done in Washington. On the third day of hearings about FDA regulations of mobile medical apps, there was still lots of fear about uncertainty and the medical device tax. Dr. Farzad Mostashari and Christy Foreman of the FDA testified in […]
This eBook, in collaboration with Care Logistics, details how hospitals and health systems can facilitate more effective decision-making by operationalizing elevated awareness.
Hospital environments are stressful scenes: blaring alarms, beeping machines, busy monitors, and endless tubes and wires all vie for doctors’ and nurses’ attention and overload their senses. “Alarm fatigue,” the phenomenon whereby health professionals get overwhelmed by and ignore the constant cacophony of alarm sirens has become a national problem. One study at Johns Hopkins […]
In an effort to showcase that government entities are doing what they can to encourage innovation too, the U.S. Department of Health and Human Services (HHS) is inviting the public to review and choose the most practical of six creative products, services and campaigns developed by its employees. The contest, called HHSinnovates, is in its […]
Greenleaf Health LLC has issued a new report titled “FDA Medical Device Enforcement Report,” and some of the numbers in there are surprising to say the least. Especially given the context of constant complaints from the medical device industry regarding its regulatory burden. The Greenleaf Health executive summary paints a picture of the broader agency […]
A Minneapolis law firm has filed a joint petition on behalf of a group of pre-revenue, small and midsized device companies, venture capitalists and inventing physicians that aims to prevent the U.S. Food and Drug Administration from unlawfully changing how the 510(k) program operates. The Minnesota Medical Device Alliance (MMDA) filed the citizen petition and […]
Am I an apologist for the pharmaceutical companies? I don’t think so, but others may disagree based on some sympathetic Whistleblower posts that have appeared in this blog. It is without question that the drug companies have been demonized and portrayed as rapacious gangs of greed who seek profit over all. Haven’t you come across the […]