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’, […]

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 […]

Kidney Damage Greatly Raises Diabetics’ Risk for Death

By Serena Gordon –HealthDay Reporter TUESDAY, Feb. 21 (HealthDay News) — People with type 2 diabetes have a higher risk of death than people without the disease, but a new study suggests that if they also have kidney damage their risk of dying is even greater. In an analysis of 22 studies, researchers from Brigham […]

Computer-Assisted Tools Alert Pediatricians to Obese Patients

First Large Study to Evaluate Impact of EHR on Childhood Obesity Evaluation By Kaiser Permanente – The Sacramento Bee, Published: Tuesday, Feb. 21, 2012 – 8:25 am PASADENA, Calif., Feb. 21, 2012 — PASADENA, Calif., Feb. 21, 2012 /PRNewswire/ — Electronic health records and embedded tools can alert and direct pediatricians so they can better manage the weight of children […]

Opinions Mixed as Managed Care Comes to Valley

Texas Tribune – by Holly Heinrich 2/21/2012. Managed health care services, which had been the subject of a recent moratorium in three Rio Grande Valley counties, will soon be available for Medicaid patients in those counties and the rest of the Valley. On March 1, Medicaid patients living in what the Texas Health and Human Services Commission classifies as […]

UTB Biomedical Research Building officially opens

  By MADELINE BUCKLEY – The Brownsville Herald, February 20, 2012 10:46 PM Officials dedicated Monday the new University of Texas at Brownsville Biomedical Research Building, which they said will produce cutting edge research to address health issues in the Rio Grande Valley and propel the school to a higher tier in medical research. The facility […]

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