Several potentially preventable deficiencies, including failure to select optimal drug doses and suitable outcome measures for a study, accounted for significant delays in the approval of new drugs by the Food and Drug Administration (FDA), according to a study in the January 22/29 issue of JAMA.
Culture
Most high-risk cardiac devices in use today approved as modifications to previously-approved devices
Boston – The Food and Drug Administration (FDA) ensures that high-risk medical devices, such as implantable cardioverter-defibrillators and pacemakers, are safe and effective through its premarket approval (PMA) pathway, during which manufacturers must collect preclinical and clinical data before the device is approved.
Many patients and physicians assume that the safety and effectiveness of newly approved drugs is well understood by the federal Food and Drug Administration (FDA) —but a new study by researchers at Yale School of Medicine shows that the clinical trials used by the FDA to approve new drugs between 2005 and 2012 vary widely in their thoroughness.
Published in the Jan. 22/29 issue of JAMA, the study is the first systematic analysis of the standard used by the FDA in making drug approval decisions.
British Muslims with diabetes may avoid attending GP surgeries to discuss fasting during the holy month of Ramadan – with potentially serious consequences for their future health, new research by the universities of Manchester and Keele shows.
The first study in the UK to explore the beliefs which influence the experience and practices of British Muslims' diabetes management found tensions often exist between observing the important religious ritual in accordance with their faith and the competing need to manage their health.
Levels of depression and anxiety in people with severe rheumatoid arthritis are higher than previously reported, according to new research.As a result of their findings, a multi-centre team led by researchers at the Arthritis Research UK Centre for Genetics and Genomics at the University of Manchester, say that patients with severe active disease, who are waiting to go onto a biological therapy, should be routinely screened for depression by their doctors.
(Boston) – The first large scale study in the U.S. on the mortality of patients with multiple sclerosis (MS) has been published and provides new information about the life expectancy of people with the disease. The study appears in the journal Multiple Sclerosis and Related Disorders.
If you have ever tried to make waffles then you are bound to be familiar with the following problem: You only get good waffles if the iron is heated to the correct temperature. The same principle applies to the manufacture of plastics parts, such as displays, facings, covers and instrument panels, using injection molding techniques. A liquid plastic melt is injected into a steel forming tool which is heated just like a waffle iron. The point is to produce a perfect cast of the tool's surface, which may be smooth like a mirror or feature a functional structure.
SAN FRANCISCO - Jan. 21, 2014 - The probability of blindness due to the serious eye disease glaucoma has decreased by nearly half since 1980, according to a study published this month in Ophthalmology, the journal of the American Academy of Ophthalmology. The researchers speculate that advances in diagnosis and therapy are likely causes for the decrease, but caution that a significant proportion of patients still progress to blindness.
Self-rated Health an Efficient and Effective Predictor of Long-Term Depression Risk
1. Evidence that access to firearms significantly increases odds of suicide and homicide
PITTSBURGH, Jan. 20, 2013 – Uninsured patients with a variety of common medical diagnoses are significantly less likely to be transferred between hospitals for treatment, according to a new study led by researchers at the University of Pittsburgh School of Medicine in collaboration with researchers at the University of Iowa and University of Toronto. They also found that women, insured or not, are less likely to be transferred between hospitals.
The first 30 seconds of a social encounter is crucial for people with symptoms of schizophrenia for establishing contact with people, according to new research carried out at Queen Mary University of London.
Using motion capture technology more commonly found in the film industry, the researchers studied social interactions of patients in a group and analysed the patterns of verbal and non-verbal communication.
Boston, MA — For patients in the early stages of multiple sclerosis (MS), low levels of vitamin D were found to strongly predict disease severity and hasten its progression, according to a new study led by Harvard School of Public Health (HSPH) investigators in collaboration with Bayer HealthCare. The findings suggest that patients in the early stages of MS could stave off disease symptoms by increasing their vitamin D intake.
(Boston) – A recent study led by Boston University School of Medicine (BUSM) shows that "practice may make perfect" when it comes to caring for patients with severe sepsis. The study showed that patients admitted to academic medical centers that care for more patients with severe sepsis have significantly lower mortality rates than patients cared for at academic medical centers with lower volumes of sepsis patients. Additionally, the superior outcomes at high volume centers were achieved at similar costs compared to the lower volume medical centers.
Boston, MA—In 2009, the first face transplant was performed at Brigham and Women's Hospital (BWH), and lead surgeon, Dr. Bohdan Pomahac has been pioneering the procedure since. However, understanding the technical challenges, particularly around how the recipient accepts or rejects the donated face, is just beginning. Following any transplant, including facial transplant, T cells in the recipient mount an immune response to the donated tissue, threatening rejection.