MedWorm provides a medical RSS filtering service. Over 6000 RSS medical sources are combined and output via different filters. This feed contains the latest medical blog items that have been tagged with 'diabetes fda'. Sat, 03 Sep 2011 02:24:04 +0100 http://www.medworm.com/index.php?rid=5130752&cid=t_183562_87_f&fid=39187&url=http%3A%2F%2Fgetbetterhealth.com%2Fwhy-this-diabetic-isnt-concerned-about-her-insulin-pump-being-hacked%2F2011.08.14 Jay Radcliffe is a fellow type 1 diabetic, and I remember reading his diabetes blog way back in the day, when I first started blogging.  We read and commented on each other’s posts, and we were both part of the blogosphere when the DOC first started to grow.  I knew he was married, had children, and did the day-to-day diabetes stuff that I did. Which is why when I read the mainstream media’s take on his pump-hacking research (this article, Insulin Pumps Vulnerable to Hacking, for example), I reached out to him immediately.  “Can I just tell you that my mother sent me this article about your research?  Do you have time to talk?” Jay was out in Las Vegas this morning, attending the Black Hat security conference, but he and I had a chance to hash it out over the ph... Better Health blogs http://www.medworm.com/rss/comments.php?id=5130752 Sun, 14 Aug 2011 14:00:57 +0100 5130752 http://www.medworm.com/index.php?rid=4841988&cid=t_183562_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FBLRCl_3VzoU%2F Last September, the FDA decided to allow the controversial Avandia diabetes pill to remain on the market. The move came after more than three years of debate over the cardiovascular risks of the which the GlaxoSmithKline drug and charges that the drugmaker failed to sufficiently disclose clinical trial data showing the magnitude of those risks (back stories here, here and here). Nonetheless, the agency made clear there would significant restrictions on accessibility to patients who are unable to control their illness by using other meds. For instance, doctors will have to document patient eligibility and patients will have to review statements describing CV safety concerns associated with Avandia and acknowledge they understand the risks. Today, though, the FDA announced the Risk Evaluatio... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4841988 Wed, 18 May 2011 23:02:52 +0100 4841988 http://www.medworm.com/index.php?rid=4696953&cid=t_183562_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2F3rag4hFYoo8%2F Might the FDA be giving MannKind the bum’s rush? Late Friday, the agency cancelled an end-of-review meeting designed to discuss the Afrezza inhaled insulin device that earlier this year was the subject of a second complete response letter. The reason for the cancellation? The potential for a government shutdown. The FDA, meanwhile, did not reschedule the meeting (see the statement). The move is the latest incident in which at least one Wall Street analyst believes the agency appears to be sending a decidedly chilly message to the MannKind team, which was asked in January to provide more safety data about Alfrezza and run two new trials - one with Type 1 diabetes patients and another with Type 2 diabetes patients (back story). “While the FDA cancelled the meeting with MannKind, ... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4696953 Mon, 11 Apr 2011 12:15:15 +0100 4696953 http://www.medworm.com/index.php?rid=4627022&cid=t_183562_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2Fzsc31rHAVPw%2F A South Carolina state court jury decided late yesterday that a Johnson & Johnson unit violated consumer protection laws by sending doctors a misleading letter in 2003 about the safety and effectiveness of the Risperdal antipsychotic. The jurors also found warning label info was deceptive. And so a judge will now decide whether $360 million in penalties will be paid, Bloomberg News writes. South Carolina argued J&J’s Ortho-McNeil-Janssen Pharmaceuticals unit engaged in “unfair and deceptive acts” by claiming Risperdal was better than competing drugs in the letter, which was sent to some 700,000 doctors nationwide, including 7,200 in the state. The FDA issued J&J a warning letter about false and misleading claims that minimized risks, such as diabetes, and o... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=4627022 Wed, 23 Mar 2011 12:05:21 +0100 4627022 http://www.medworm.com/index.php?rid=3827348&cid=t_183562_150_f&fid=35777&url=http%3A%2F%2Ffeedproxy.google.com%2F%7Er%2FPharmalot%2F%7E3%2FPJSB-Co_w5E%2F Here is an interesting dichotomy: At the same time that AstraZeneca is forking out tens of millions of dollars to settle thousands of product-liability lawsuits claiming the risks of its Seroquel antipsychotic were not properly disclosed (see this), the drugmaker is tagged by the FDA for distributing promotional material that, among other things, fails to mention the risk that promped the lawsuits - a link to diabetes. A July 29 letter sent by the Division of Drug Marketing and Advertising Communications notes that the efficacy of Seroquel XR was overstated and risk info was omitted in so-called leave-behind sheets. For instance, various studies were cited, but overstated remission rates, the FDA scolded. “These claims misleadingly suggest that patients will achieve ‘remission... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=3827348 Thu, 05 Aug 2010 12:19:23 +0100 3827348 http://www.medworm.com/index.php?rid=3399117&cid=t_183562_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2010%2F03%2Fraising-the-bar-on-glucose-meter-accuracy-the-industry-recommends.html More details on the recent FDA Hearings on the accuracy of blood glucose monitoring devices: I was surprised by the report from patient advocate Ellen Ullman on Monday, noting that patient interests seem to be grossly underrepresented, and lots of experts seem to believe that the status quo of +/- 20% error margin is all [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=3399117 Wed, 24 Mar 2010 13:00:35 +0100 3399117 http://www.medworm.com/index.php?rid=3331267&cid=t_183562_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2F5TNNxE52udk%2F All is not well in the land of insulin pumps — the devices that deliver insulin to mostly Type 1 diabetics — and the FDA wants to put a spotlight on the problem. Noting that there had been 18 recalls of pumps over five years because of hardware and software problems, the FDA said that “device problems critical to insulin pumps exist across manufacturers.” The agency has called a meeting of outside experts for Friday to see what can be done about the risks. The FDA didn’t cite particular manufacturers, but insulin-pump makers include Johnson & Johnson, Medtronic and Roche Holding. See comments from those companies and other details from Reuters and Dow Jones Newswires. People with Type 1 diabetes produce little or no insulin and increasing numbers are usin... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=3331267 Wed, 03 Mar 2010 23:06:40 +0100 3331267 http://www.medworm.com/index.php?rid=2616831&cid=t_183562_134_f&fid=34841&url=http%3A%2F%2Fwww.diabetesmine.com%2F2009%2F07%2Ffda-cracking-down-on-accuracy-of-glucose-monitors.html The New York Times reports today that the rise in the use of home glucose monitors, also in hospitals, is pushing the Food and Drug Administration toward a possible crack-down on accuracy standards.  Some of you might say it’s about time, considering that current standards allow a margin for error of up to 20%, which [...] (Source: Diabetes Mine) Diabetes Mine blogs http://www.medworm.com/rss/comments.php?id=2616831 Sun, 19 Jul 2009 21:54:52 +0100 2616831 http://www.medworm.com/index.php?rid=2414765&cid=t_183562_87_f&fid=34935&url=http%3A%2F%2Fmedicine.com.my%2Fwp%2F%3Fp%3D6992 VIDEO: Cheerios Called Unapproved New Drug by FDA, Depression May Increase Foot Ulcer Risk in Diabetics, Beer May Increase Psoriasis Risk Among Women strWebsiteID = window.document.location.toString();strSplitWeb = strWebsiteID.split("/")strWebsiteID = strSplitWeb[2];document.write(”“); from the Malaysian Medical Resources VIDEO: Cheerios Called Unapproved New Drug by FDA, Beer May Increase Psoriasis Risk Among Women (Source: Malaysian Medical Resources) Malaysian Medical Resources blogs http://www.medworm.com/rss/comments.php?id=2414765 Fri, 15 May 2009 04:00:00 +0100 2414765 http://www.medworm.com/index.php?rid=2098224&cid=t_183562_87_f&fid=36224&url=http%3A%2F%2Ffeeds.wsjonline.com%2F%7Er%2Fwsj%2Fhealth%2Ffeed%2F%7E3%2FIZnCbMl8GVE%2F The FDA should do a lot more to police potential conflicts of interest among researchers conducting clinical trials of experimental drugs and medical devices, a government watchdog says. Read the report, out today from the office of the Inspector General at the Department of Health and Human Services. The IG’s office reviewed the paperwork for studies tied to the 118 marketing applications approved by FDA in FY ‘07. They found that 42% of approved applications were missing financial information, and only 1% of investigators disclosed financial ties. What’s more, the FDA can’t know whether all clinical investigators have submitted financial disclosure statements, because the agency never gets a complete list of all clinical investigators. The report recommends some p... WSJ.com: Health Blog blogs http://www.medworm.com/rss/comments.php?id=2098224 Tue, 13 Jan 2009 10:09:56 +0100 2098224 http://www.medworm.com/index.php?rid=2090475&cid=t_183562_134_f&fid=36985&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fsugarstats%2F%7E3%2F505564092%2F You might have heard, but if not please go over to http://www.healthefda.com to get more info and sign this petition. The FDA has its place for many things and I’m sure they have the best of intentions at heart. But they could be doing a whole lot better in regards to diabetes and new diabetic [...] (Source: SugarStats.com - Simple, Online Blood Sugar Tracking for Diabetes Management) SugarStats.com - Simple, Online Blood Sugar Tracking for Diabetes Management blogs http://www.medworm.com/rss/comments.php?id=2090475 Wed, 07 Jan 2009 23:23:16 +0100 2090475 http://www.medworm.com/index.php?rid=1564171&cid=t_183562_150_f&fid=35777&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmalot%2F%7E3%2F325191337%2F An FDA advisory committee voted 14 to 2 that all new diabetes drugs should undergo longer studies to ensure cardiovascular risks aren’t increased, a move that is expected to cost drugmakers untold millions of dollars to conduct additional clinical trials, the Associated Press reports. The recommendation comes less than a year after the FDA was criticized for its handling of heart risks connected with Glaxo’s widely used Avandia diabetes pill, which was approved in 1999. The agency, however, didn’t add a warning about potential heart risks until last November, the AP notes. The majority of the panel said drugmakers could begin safety testing, which is expected to take between five and seven years to complete, before they submit drugs to the FDA and finish the studies after... Pharmalot blogs http://www.medworm.com/rss/comments.php?id=1564171 Wed, 02 Jul 2008 21:03:14 +0100 1564171 http://www.medworm.com/index.php?rid=1455504&cid=t_183562_134_f&fid=36985&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2Fsugarstats%2F%7E3%2F285376107%2F Diabetes Hand Foundation and TuDiabetes/OneTouch Partnership Via TuDiabetes.com Big announcement from our friend Manny Hernandez from TuDiabetes.com on exciting new developments, projects and partnerships. Mainly the creation of the Diabetes Hand Foundation and partnership with OneTouch: “The Diabetes Hand Foundation is a non-profit that we formed to serve as an umbrella for TuDiabetes.com, EsTuDiabetes.com, Word In [...] (Source: SugarStats.com - Simple, Online Blood Sugar Tracking for Diabetes Management) SugarStats.com - Simple, Online Blood Sugar Tracking for Diabetes Management blogs http://www.medworm.com/rss/comments.php?id=1455504 Wed, 07 May 2008 13:50:05 +0100 1455504 http://www.medworm.com/index.php?rid=1072409&cid=t_183562_97_f&fid=35050&url=http%3A%2F%2Ffeeds.feedburner.com%2F%7Er%2FPharmaGazette%2F%7E3%2F195622211%2Ftakeda_pharmaceuticals_actos_g.html In June 2007, during congressional hearings, the U.S. Food and Drug Administration revealed that it has called for the strongest black box warning possible on Actos.After reviewing postmarketing adverse event reports, the FDA that Actos (pioglitazone), approved to treat Type 2 diabetes, required a black box warning emphasizing that the drug may cause or worsen heart failure in certain patients. The warning covers all thiazolidinedone class drugs including Avandia, Actos, Avandaryl, Avandamet and Duetact."Under FDA's postmarketing surveillance program, we carefully monitor new safety information for marketed drugs and take appropriate action when necessary to inform patients and health care providers of new information," said Steven Galson, M.D., M.P.H., director of FDA&#... PharmaGazette blogs http://www.medworm.com/rss/comments.php?id=1072409 Wed, 05 Dec 2007 16:00:21 +0100 1072409 http://www.medworm.com/index.php?rid=674826&cid=t_183562_117_f&fid=34612&url=http%3A%2F%2Fwww.thedoctorweighsin.com%2Fjournal%2F2007%2F6%2F9%2Ftruth-and-consequences-the-sad-tale-of-avandia-gsk-the-fda-a.html Medical science has always benefited from a healthy debate about the risks and benefits of various treatments. Doctors and other health professionals are trained to think critically about published data and to be cautious about recommending new (and old) treatments that have not met the highest standards of safety and efficacy. GSK's Avandia (from the News&Observer)Then they leave the relatively protected environment of their training institutions and enter the real world of high pressure, big business that is medicine today. Squeezed by time pressures, struggles over reimbursement, marketeers pushing their products, and patients demanding stuff they see on TV, they start to prescribe products and recommend treatments that they may not have under different circumstances. I’ve bee... The Doctor Weighs In blogs http://www.medworm.com/rss/comments.php?id=674826 Sat, 09 Jun 2007 22:22:07 +0100 674826