Category: Regulations
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Community Management Can Sustain Small Fisheries
Small-scale commercial fishing operations, the kind that often feed millions of people worldwide, can be sustained when managed cooperatively with their communities. This conclusion is drawn from a study published 5 January in the online issue of the journal Nature (paid subscription required). Nicolas Gutiérrez, a University of Washington fisheries scientist and lead author of…
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Study: Pill Splitting Inaccurate, Potentially Dangerous
A study in the January 2011 issue of the Journal of Advanced Nursing (paid subscription required) suggests that the practice of cutting prescription tablets in half results in wide dosage variations, which can be dangerous for patients needing accurate doses of their medicines. The research was done by the Faculty of Pharmaceutical Sciences at Ghent…
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Recycled Haitian Concrete Found Safe, Strong
Nearly one year after a 7.0-magnitude earthquake rocked Haiti, engineering and concrete experts at Georgia Institute of Technology in Atlanta report that concrete and other debris in Port-au-Prince can be safely recycled into strong new construction material. Their findings appear in the Bulletin of the American Ceramic Society, published today (4 January 2011). Georgia Tech…
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Standards Proposed for Prescription Drug Labels
The U.S. Pharmacopeial Convention (USP), a standards–setting body for prescription and over–the–counter medicines, has prepared a set of standards to guide the content, language, format, and appearance of prescription medication labels in the U.S. The draft standards are open for a 90-day public comment period. USP says the standards, now in draft, reflect how patients…
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FDA Clears Stem Cell Trial for Macular Degeneration
Advanced Cell Technology Inc. (ACT), a biotechnology company in Marlborough, Massachusetts, said today that the U.S. Food and Drug Administration (FDA) has cleared its application to test-treat dry age-related macular degeneration using human embryonic stem cells. Dry age-related macular degeneration (AMD) is the leading cause of vision loss and blindness among Americans who are age…
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FDA Approval Sought for Heart Failure Device
HeartWare International Inc., in Sydney, Australia says today it submitted a Pre-Market Approval application to the U.S. Food and Drug Administration (FDA) for its HeartWare Ventricular Assist System. The system acts as a bridge to heart transplantation for patients with end-stage heart failure. Premarket approval by FDA is the required process of scientific review to…
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Biotech Makes Available Stem Cell Lines to Researchers
BioTime Inc., a biotechnology company in Alameda, California said today it concluded an agreement to make five research-grade human embryonic stem (hES) cell lines available to University of California (UC) system researchers. These lines are genetically identical to the Good Management Practice (GMP)-compliant hES cell lines that will be made available to researchers in California…
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Health Care Systems to Share Practices on Quality, Costs
Six health care systems in the U.S. announced today a collaboration to improve health care quality while reducing costs. Participating organizations — representing networks of hospitals, clinicians, and researchers — include Dartmouth-Hitchcock, Cleveland Clinic, Denver Health, Geisinger Health System, Intermountain Healthcare, and Mayo Clinic. The Collaborative, as it is called, promises to share data on…
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Pharma R&D Q3 Output Keeps Pace, But Revenue Slides
The financial research company Fitch Ratings said in a report issued today that the global pharmaceutical companies followed by the company maintained a modest, but steady pace of new product approvals and regulatory filings to U.S., European, and Japanese regulators in the third quarter of 2010. The report, “Global Pharmaceutical R&D Pipeline: Third-Quarter 2010” (subscription…
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‘Green’ Treatments Fail to Stop Bacteria in Commercial A/C
A recent study by University of Pittsburgh researchers indicates that non-chemical water-treatment devices may not work as they claim and can allow dangerous bacteria to flourish in the cooling systems of hospitals and commercial offices, almost as much as they do in untreated water. The university says the study, conducted by its school of engineering,…