New FDA guidance on considerations used in device approval, de novo decisions Clinical data, risks, benefits and patient risk tolerance outlined in process

FDA.gov: March 27, 2012. The U.S. Food and Drug Administration today published a first-of-a-kind guidance for medical device manufacturers, describing how the benefits and risks of certain medical devices are considered during pre-market review. Premarket approval (PMA) is the FDA process of scientific and regulatory review used to evaluate the safety and effectiveness of Class III medical devices. […]

Drugs May Cause 5 Times More Side Effects Than Previously Thought

New research on Drug Side Effects done at Stanford School of Medicine has discovered nearly 5 times the 70 or so potential reactions that are listed on the average drug insert. (PRWEB) March 24, 2012. Prescription medications usually always carry a rather frightening (and long) list of possible side effects. These drug side effects may range from mild symptoms […]

Setting the Record Straight on Transparency

Phrma.org: by Karl Uhlendorf on 3/23/2012. There’s been some chatter in the blogosphere lately around our sector’s commitment to transparency in clinical trials, with an unfortunate lack of clarity and context. To set the record straight, here’s a quick historical overview of our considerable and consistent efforts in this important area. It should be well recognized […]

10 Facts Every Woman Should Know About Clinical Trials

Empowher:  by Lynette Summerill, March 22, 2012 – 8:36am. Fact 1: All clinical trials are voluntary. If you meet the criteria for a clinical trial, you always have the right to choose whether or not you will participate, and you have the right to leave a clinical trial at any time, for any reason. The level of […]

Pharma gets social: pharma lessons in social media and clinical trials

Pharmaphorum: Daniel Ghinn, March 21, 2012. The use of social media in supporting medical research is rapidly moving from experimental pilots to informed strategies. Indeed, an increasing number of companies and healthcare stakeholders are exploring how social media can support clinical trials activity, and as they do so, some interesting trends are emerging. In this article […]

Researchers discover drug target for stimulating recovery from stroke

Medicalxpress.com: Neuroscience: March 21, 2012. Investigators at the Stanford University School of Medicine have shown that removing a matched set of molecules that typically help to regulate the brain’s capacity for forming and eliminating connections between nerve cells could substantially aid recovery from stroke even days after the event. In experiments with mice, the scientists demonstrated that […]

Chemicals in plastic linked to rise in obesity and diabetes

Independent.co.uk: MARTIN HICKMAN, TUESDAY 20 MARCH 2012 Man-made chemicals present in homes, schools, offices, cars and food are probably contributing to the sharp rise in obesity and diabetes in western societies, according to a review of scientific literature published today. Until now lifestyle factors such as lack of exercise and poor diet were believed to be the […]

Blueberries and apples tied to lower diabetes risk

Reuters.com: By Aparna Narayanan, NEW YORK | Fri Mar 16, 2012 5:24pm EDT. Eating more blueberries, apples and pears may be linked to lower risk of diabetes, according to a new U.S. study. These fruits are loaded with flavonoids, a natural compound present in certain fruits, vegetables and grains, which some research has tentatively tied to heath benefits such […]

White rice consumption and risk of type 2 diabetes: meta-analysis and systematic review

BMJ 2012; 344 doi: 10.1136/bmj.e1454 (Published 15 March 2012. Abstract Objectives To summarise evidence on the association between white rice consumption and risk of type 2 diabetes and to quantify the potential dose-response relation. Design Meta-analysis of prospective cohort studies. Data sources Searches of Medline and Embase databases for articles published up to January 2012 using keywords that included both rice intake […]

H. Pylori Linked to Diabetes Marker

MedPage Today: By Michael Smith, North American Correspondent, Published: March 14, 2012. The bug that causes ulcers may also play a role in the development of type 2 diabetes, researchers said. In two large cohorts, Helicobacter pyloricolonization was positively associated with levels of glycosylated hemoglobin (HbA1c), a marker of impaired glucose tolerance, according to Yu Chen, PhD, and Martin […]

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