In recognition of World Rare Disease Day, the U.S. Food and Drug Administration and the European Medicines Agency (EMA) today announced a more streamlined process to help regulators better identify and share information throughout the development process of orphan drug and biologic products, which are developed specifically to treat rare medical conditions.
No one looks forward to the cold and flu season. Americans catch an estimated 1 billion colds each year. In fact, the common cold is among the leading reasons for visiting a doctor and for missing school or work
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Colds and Flu and CAM: At a Glance
The U.S. Food and Drug Administration today announced an initiative to reduce unnecessary radiation exposure from three types of medical imaging procedures: computed tomography (CT), nuclear medicine studies, and fluoroscopy. These procedures are the greatest contributors to total radiation exposure within the U.S
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FDA Unveils Initiative to Reduce Unnecessary Radiation Exposure from Medical Imaging
The National Center for Complementary and Alternative Medicine (NCCAM) welcomes five new members to the National Advisory Council for Complementary and Alternative Medicine (NACCAM). The council serves as the principal advisory body to NCCAM, the lead Federal agency for complementary and alternative medicine (CAM) research, and a component of the National Institutes of Health. The council is composed of physicians, scientists, licensed CAM practitioners, and members of the public who contribute their time and expertise over a four-year term
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NCCAM’s Advisory Council Welcomes Five New Members
The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine)
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FDA Announces Safety Risk Associated with HIV Drug
The U.S.
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FDA Approves Morphine Sulfate Oral Solution for Relief of Acute and Chronic Pain
Emmeline Edwards, Ph.D., a specialist in neural mechanisms of complex behaviors, has been appointed director of the Division of Extramural Research at the National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health. The Division of Extramural Research develops and oversees NCCAM-funded research and research training programs. Division staff provide guidance regarding NCCAM research interests and priorities, and funding mechanisms and opportunities.
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Dr. Emmeline Edwards Named Director of NCCAM’s Division of Extramural Research
The U.S. Food and Drug Administration today announced that data from a recent review of the Spiriva HandiHaler, a long-acting respiratory treatment for chronic obstructive pulmonary disease (COPD), do not support an increased risk of stroke, heart attack, or death in patients using the medicine.
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FDA Updates Earlier Guidance on Respiratory Treatment Spiriva HandiHaler
The National Advisory Council for Complementary and Alternative Medicine (NACCAM) is charged with the responsibility of advising, consulting with, and making recommendations to the Director, NCCAM, on matters relating to the research activities and functions of the Center. The role and responsibilities of the council members include secondary review of grant applications in light of NCCAM scientific program priorities and program balance. The agenda for the upcoming February meeting is posted for your review
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Advisory Council Meeting, February 5th 2010
The Medicines Company (NASDAQ: MDCO) announced today that it is voluntarily recalling eleven (11) lots of Cleviprex ® (clevidipine butyrate) injectable emulsion due to the potential presence of visible particulate matter which has been observed in some vials during a routine annual inspection. The affected Cleviprex lots are 61-978-DW, 61-979-DW, and 61-980-DW, Exp. 01/2010; 68-404-DJ, 68-405-DJ, and 68-406-DJ, Exp.
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The Medicines Company Issues a Nationwide Recall for Certain Lots of Cleviprex® That May Contain Particulate Matter