Notice to Industry: Postmarketing Requirements – Postmarket studies and clinical trials

FDA.gov 02/21/2012.  FDA’s mission is to ensure that safe and effective new drugs are available as quickly as possible and that drugs already marketed remain safe and of the highest quality for as long as the drugs remain on the U.S. market.  As part of this authority, industry should be on notice that FDA intends to vigorously […]

Budget Woes Stall Clinical Trials and Stymie Sites

Bio-IT World By Ann Neuer   February 21, 2012 | Imagine buying a new car or a new house but not knowing the price until the papers have already been drawn up and it’s time to sign on the dotted line.  According to Christine Pierre, President of RxTrials, that’s exactly the situation investigative sites face as they attempt to negotiate […]

Few RA clinical trials compare one drug to another

Reuters Health: By Kerry Grens NEW YORK | Fri Feb 17, 2012 4:44pm EST To test whether a new drug is an improvement over existing treatments, the ideal clinical trial would compare the medications head to head, but few trials of rheumatoid arthritis treatments happen that way, according to a new study. Instead, researchers found that for certain new […]

Information wants to be free, but when it comes to clinical trials can we afford to let it be?

Future-Science: Paul Wicks – February 2012, Vol. 2, No. 2, Pages 125-127 , DOI 10.4155/cli.11.182 (doi:10.4155/cli.11.182) ‘Information (or data) wants to be free’ – so goes the mantra of hackers and data activists. In the past this meant computer geeks hacking into secure private networks to fulfill their own curiosity or liberate secret knowledge. Today, voluntary ‘data liberation’, […]

Being Born in Another Country May Protect Against Stroke for U.S. Hispanics

NEW ORLEANS, Feb. 21, 2012 /PRNewswire-USNewswire/ — New research finds foreign-born Hispanics now living in the United States appear to be less likely to have a stroke compared to non-Hispanic white people.  The research was released today and will be presented at the American Academy of Neurology’s 64th Annual Meeting in New Orleans April 21 to April 28, 2012.  The research is […]

Daily diet soda may increase risk of heart attack, stroke: study

Reuters – Sun Feb 19, 2012 9:14pm EST. Diet soda may benefit the waistline, but people who drink it every day may have a heightened risk of heart attack and stroke, according to a new U.S. study. Although the researchers, whose work appeared in the Journal of General Internal Medicine, found that older adults who drank […]

Post-Stroke Speech Problems Inflate Cost of Treatment

US Health News  (HealthDay News) – THURSDAY, Feb. 16, 2012. Average medical costs for a stroke patient with language impairment (aphasia) are more than $1,700 higher in the first year after stroke than for a patient without aphasia, a new study finds. Researchers analyzed the medical records of 3,200 Medicare patients in South Carolina who had […]

SK Biopharmaceuticals to Initiate Phase 2 Trials in US

Business Wire – February 21, 2012 07:55 PM. SEOUL, South Korea–(BUSINESS WIRE)–South Korean pharmaceutical company SK Biopharmaceuticals announced yesterday that they have initiated a phase 2 trial in the US for patients suffering with diabetic peripheral neuropathy using their new chemical entity SKL11197. Recently, SK Biopharmaceuticals successfully completed their phase I trials in the US. Diabetic […]

Taiwan, U.S. approve trials of locally developed diabetes drug

Focus Taiwan: 2012/02/20 22:57:39 Taipei, Feb. 20 (CNA) The first phase of clinical trials of a locally developed anti-diabetes drug candidate, code-named DBPR108, will soon be launched both in Taiwan and the United States, the National Health Research Institutes (NHRI) announced Monday. “Both Taiwan and U.S. health authorities have given the green light to phase 1 […]

First of its Kind Research Project for Mobile Diabetes Management

PHILADELPHIA, FEB. 21, 2012 — /PRNewswire/ — Can mobile tools and services help people with diabetes control their condition? To find out, dLife, the nation’s premier online diabetes community resource and hub, and its partner, Vital mHealth, a digital healthcare marketing agency based in Philadelphia, are launching a first-of-its-kind tracking study within a mobile application dedicated to helping people […]

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