FDA :: Actions Program for Medical Devices – Enhancing Patient Safety
The U.S. Food and Drug Administration (FDA) today announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
The U.S. Food and Drug Administration (FDA) today announced its action plan for strengthening the way it monitors the safety of medical devices after they reach the marketplace.
Over the last half century, researchers have found that mineral surfaces may have played critical roles organizing, or activating, molecules that would become essential ingredients to all life–such as amino acids (the building blocks of proteins) and nucleic acids (the essence of DNA). But which of the countless possible combinations of biomolecules and mineral surfaces were key to this evolution? This vexing question has stumped scientists for years because of the sheer volume of possibilities.
For over 30 years, scientists believed that monoamines are low in the brain during major depressive episodes. However, no one ever found a convincing explanation for monoamine loss. Dr. Jeffrey Meyer and colleagues discovered that higher levels of MAO-A is the primary process that lowers monoamine levels. Having more MAO-A leads to greater breakdown of chemicals like serotonin. Based on these results, and work from previous publications, Dr. Meyer developed an advanced monoamine model of depression.
An international professional society has issued a patient?s bill of rights for the treatment of eating disorders, conditions that affect an estimated 30 million Americans, most of them young women. For 2 million, symptoms will progress to full-blown anorexia nervosa and approximately 10 percent will die from the disease. Treatment is often complex and typically involves not only the patient, but friends and family as well.
WFP has welcomed a generous contribution of US$2 million from the Russian Federation to WFP?s emergency operation in Kenya, praising the first donation from the Russian Federation to WFP?s work in East Africa.
IDM Pharma (NASDAQ:IDMI) announced today that the company has submitted a Marketing Authorization Application (MAA) in eCTD format (electronic common technical document) to the European Medicines Agency (EMEA) for Mepact (mifamurtide for injection), requesting approval for its use in the treatment of patients with newly diagnosed resectable high-grade osteosarcoma following surgical resection in combination with post-operative multi-agent chemotherapy. This announcement follows the October 25, 2006 submission of a New Drug Application (NDA) for Junovan (mifamurtide for injection) to the Food and Drug Administration (FDA) in the United States.
Researchers at the University of Pennsylvania School of Medicine have discovered how the Kaposi’s sarcoma-associated herpesvirus (KSHV) subverts a normal cell process in order to promote tumor growth. The finding, published in the most recent issue of PLoS Pathogens, offers new potential strategies for treating Kaposi’s sarcoma and other cancers associated with viruses
Which works best in fighting the risk factors for diabetes ?exercise or diet? Exercise and diet work equally well in reducing the risk factors for diabetes, a new study finds.
Difficulties in the heart’s ability to fill with blood are common causes of heart failure — and appear to be as significant in placing a heart patient at risk of death as are deficiencies in the heart’s ability to pump blood, new research from Mayo Clinic shows.
How do the disabled conquer their physical and mental constraints to step on the stage and perform drama, dance and music? Come and see the International Festival of Inclusive Arts’ drama night and you will get the answer.